# job

ext_id: 4495655008
published: 2025-01-22 16:21:30+00:00
title: Training Lead - 1st Shift - Days Off: Thursday & Friday
location: Baltimore, MD
application_url: https://job-boards.greenhouse.io/homechefinternalemployees/jobs/4495655008
experience_level: SE
language: en
has_remote: False
description:
<p> </p>
<p>This role follows a <strong>1st</strong><strong> shift</strong> schedule, working from <strong>7 AM</strong> to <strong>3:30 PM</strong>, with designated days off on <strong>Thursday and Friday.<br/></strong></p>
<p>The Training Lead is responsible for all new production hires and ensuring that they are adequately trained on all production processes. Training leads are also responsible for ensuring that online refresher training is completed as assigned for the production teams (associates and leads).</p>
<p><span><strong>Detailed Responsibilities</strong></span></p>
<p><strong><em>On the Floor Training &amp; Facilitation</em></strong></p>
<p>The Training Lead is responsible for working with the Training Superintendent to drive a culture of community and positivity in the training program and on the production floor while working to set up new hires for success in their new roles. The training lead will </p>
<ul>
<li>Be an expert on all aspects of the production floor to include Production processes as well as an understanding of how supporting departments work with Production</li>
<li>Assist and coach new hourly employees on floor processes and procedures</li>
<li>Understand the training program, policies, and procedures</li>
<li>Track and document employee progress on the floor with provided checklist of skills and competencies</li>
<li>Work directly with the Training Superintendent to identify areas of opportunity to drive change and improve the training program</li>
<li>Develop and maintain strong working relationships with Production Supervisors and Shift Managers</li>
<li>Understand key KPIs and demonstrate ability to effectively communicate KPI targets to new and existing associates</li>
</ul>
<p><strong><em>Overseeing Production Activities of New Hires</em></strong></p>
<p>A Training Lead is responsible for setting up and overseeing a portioning table or meal bagging line when on the production floor. Responsibilities may include:</p>
<ul>
<li><em><strong>Pre-op set up</strong> </em>
<ul>
<li>Well versed in setting up portioning and meal bagging tables according to the Production plan</li>
</ul>
</li>
<li><em><strong>Conducting ingredient quality checks</strong></em>
<ul>
<li>Must be familiar with each item in the meal bag and ensure the quality of the product by opening containers of portioned items and conducting weight checks on ingredients</li>
<li>Must be familiar with standard measurements and conversions (e.g. 8oz in 1c) in order to reduce the chance that portioning errors occurs</li>
</ul>
</li>
<li><strong><em>Conducting labeling quality checks</em></strong>
<ul>
<li>Ensuring  the ingredient label on the packaging (e.g bag, bottle, jar) matches the ingredients listed on the production sheet during portioning</li>
<li>Must make sure the line is using the correct meal bagging labels</li>
<li>Must be trained on how to use the electronic label dispensers and set them up for the table as necessary</li>
</ul>
</li>
<li><strong><em>Utilizing Production Sheets</em></strong>
<ul>
<li>Must be able to identify all sections listed on the production sheet</li>
<li>Must be able to complete all sections listed on the production sheet</li>
<li>Must work with FSQA to verify all ingredients on the meal bag line and complete the meal bag sign off on the production sheet prior to starting the line</li>
<li>Must work with FSQA to ensure meal bag checks are conducted every hour to minimize errors </li>
</ul>
</li>
</ul>
<ul>
<li><em><strong>Shipping</strong></em>
<ul>
<li>Understands the Boxing Call out Sheet and how to use it</li>
<li>Makes sure the SOPs for box packing and shipping are being followed throughout the entire shift</li>
<li>Ensures new employees understand the importance of keeping pace on the line as well as common bottlenecks</li>
</ul>
</li>
<li><em><strong>Managing waste</strong></em> 
<ul>
<li>Ensuring line does not overproduce portions or meal bags and therefore cause food waste (i.e. only producing what is required) </li>
<li>Making sure employees are not wasting food or packaging (i.e. bags, bottles, jars) while portioning and meal bagging</li>
</ul>
</li>
</ul>
<p><strong><em>Coaching &amp; Development</em></strong></p>
<p>A Training Lead is responsible for overseeing production employees both on the production floor and in the classroom, when necessary. This may include:</p>
<ul>
<li>Ongoing evaluation and feedback of individuals’ core competencies and skills </li>
<li>Facilitating Alchemy training content in the classroom in the absence of the Training Superintendent</li>
<li>Work with new employees to instill HC values and behaviors that they will be held accountable to including, but not limited to, ownership, respect for others, and accountability </li>
<li>Manages conflict among employees working at their pod/table as needed but escalates any serious issues/concerns to the Shift Manager</li>
<li>Approachable and collaborative with all hourly production associates and leads</li>
<li>Cultivates culture of mutual respect and demonstrates a “Safety First, Quality Always” mentality</li>
<li>Leads by example and embodies Home Chef values of Customer First, Best-in-Class Team, Take Ownership, Pursue Excellence, and Deliver Happiness </li>
</ul>
<p><strong><em>General Responsibilities</em></strong></p>
<ul>
<li>Follow the facility GMP’s and help enforce them throughout the facility</li>
<li>Support the efforts of the company to maintain our food safety system (SQF) and quality programs as well as our employee safety initiatives</li>
</ul>
<p>This position requires 0% travel. </p>
<p><span><strong>Qualifications</strong></span></p>
<p>The requirements listed below are representative of the knowledge, skill, ability and/or other characteristics needed for this role. Reasonable accommodations may be made to enable individuals with disabilities.</p>
<ul>
<li>General high school degree, or equivalent, (e.g. GED)</li>
<li>6+ months of production/warehouse environment required</li>
<li>Desire to train and willingness to learn new skills</li>
<li>Ability to work in a fast-paced environment alongside others as a team</li>
<li>Open availability to work nights and weekend shifts </li>
<li>Must be able to lift up to 50 pounds with or without reasonable accommodation</li>
<li>Must have floor presence and be able to stand/walk for up to 10-12 hours</li>
</ul>
<p> </p>
<h2><em>More About Us</em></h2>
<h3><span><strong>Perks and Benefits</strong></span></h3>
<ul>
<li>Candidates can experience Home Chef as a customer - enter promo code PEOPLE30 for $30 off your first order!</li>
<li>Medical, dental, vision, life and disability insurance available</li>
<li>Paid holidays, sick time and vacation time</li>
<li>401k program</li>
<li>Flexible spending accounts for qualified medical, dependent care, parking, or transit expenses</li>
</ul>
<h3><strong><span>How We Work Together</span></strong></h3>
<p><strong>We are humble team players.</strong><br/>We are warm and gracious with team members and customers. We seek feedback to improve ourselves - and respectfully listen to and accept input.</p>
<p><strong>We are pragmatic next-level thinkers.</strong><br/>We come up with novel and unique ideas. We explore new strategies to avoid being constrained by conventional thinking.</p>
<p><strong>We take ownership.</strong><br/>We approach ambiguous problems, prepared to dive in, get curious, and learn more. We are results-driven, always challenging ourselves to exceed goals.</p>
<h3><span><strong>Be at Home at Home Chef</strong></span></h3>
<p>We all show up authentically at Home Chef. Our team includes individuals with a variety of identities, backgrounds, and perspectives. You can trust that you’ll be able to bring your whole self to an inclusive and enjoyable workplace.</p>
<p>We welcome people of all races, colors, religions, national origin or ancestry, sex (including sexual identity), age, physical or mental disabilities, pregnancy, veteran or military status, unfavorable discharge from military service, genetic information, sexual orientation, marital status, order of protection status, citizenship status, arrest record or expunged/sealed convictions, or any other legally recognized protected basis under federal, state, or local law.</p>
<p>Home Chef is committed to the full inclusion of all qualified individuals. As part of this commitment, Home Chef will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, or to receive other benefits and privileges of employment, please contact our People team at <a href="mailto:hr@homechef.com" target="_blank">hr@homechef.com</a>.</p>
<h3> </h3>
<p> </p><p>Home Chef offers the base salary range as posted below, with the exact offer depending on factors such as geographic location, experience, skills, and internal equity. While compensation is within the provided range, it is not typical for offers to be made at the upper end. In addition to base salary, Home Chef provides a comprehensive benefits package, including healthcare coverage, 401k match, and paid time off.</p>Maryland Pay Range<span>$22.50</span><span>—</span><span>$22.50 USD</span><p>To view the California Applicant Notice <a href="https://drive.google.com/file/d/135wbRekJnPzHcuLL5aOjdbYWJ0U-v9J0/view?usp=sharing" target="_blank">click<span> here</span></a></p>


ext_id: 7826445002
published: 2025-01-23 08:19:49+00:00
title: Account Payable Specialist
location: Samutprakarn10540, Thailand
application_url: https://job-boards.greenhouse.io/hyva/jobs/7826445002
experience_level: MI
language: en
has_remote: False
description:
<p><strong>About Us</strong></p>
<p>Hyva Group is a leading global provider of innovative and highly efficient transport solutions for the commercial vehicle and environmental service industries. The company is committed to the development, production, marketing and distribution of components used in hydraulic loading and unloading systems on trucks and trailers. Its products are used worldwide across a range of sectors including transport, construction, mining, materials handling and environmental services providers.</p>
<p>Founded in 1979, the company is headquartered in Alphen aan den Rijn in The Netherlands and operates in more than 110 countries with over 3,500 employees around the world. The Hyva Group encompasses more than 30 subsidiaries globally, with an extraordinary sales and service coverage and 14 production facilities in Brazil, China, Germany, India, and Italy, with more than 20,000 customers.</p>
<p> </p>
<p><strong>About The Role</strong></p>
<p>The <strong>Accounts Payable Specialist</strong> in our <strong>Thailand Office, </strong>you will perform accounting and clerical tasks related to the efficient maintenance and processing of accounts payable transactions.</p>
<p><strong>Your key responsibilities will include but not limited to:</strong></p>
<ul>
<li>Calculate, post business transactions, process invoices, verify financial data for use in maintaining accounts payable records, and provide other clerical support necessary to pay the obligations of the organization</li>
<li>Review and verify invoices and check requests</li>
<li>Sort, code and match invoices</li>
<li>Set invoices up for payment</li>
<li>Track expenses and process expense reports</li>
<li>Prepare and process electronic transfers and payments</li>
<li>Prepare and perform check runs</li>
<li>Post transactions to journals, ledgers and other records</li>
<li>Reconcile accounts payable transactions</li>
<li>Prepare analysis of accounts</li>
<li>Monitor accounts to ensure payments are up to date</li>
<li>Research and resolve invoice discrepancies and issues</li>
<li>Correspond with vendors and respond to inquiries</li>
<li>Produce monthly reports</li>
<li>Assist with month end closing</li>
<li>Provide supporting documentation for audits</li>
<li>Reconcile bank statements</li>
<li>Submit tax filings for PND.1, PND.3, PND.53, and PP.30 online</li>
</ul>
<p><strong>About You</strong></p>
<p><strong><em>To be successful in this role you will have:</em></strong></p>
<ul>
<li><strong>Bachelor’s Degree </strong>in Bachelor Degree of Finance/Accounting, or a related field.</li>
<li><strong>1-3 years</strong> of accounts payable and general accounting experience.</li>
<li>Solid understanding of <strong>basic accounting principles, fair credit practices</strong> and <strong>collection regulations.</strong></li>
<li>Able to communicate professionally in both <strong>English and Thai.</strong></li>
<li>Proficiency in <strong>Excel</strong> and experience with <strong>Sera and One Stream reporting</strong> (an advantage).</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Ability to work both independently and as part of a team.</li>
<li>Proactive and self-motivated with a sense of urgency.</li>
</ul>
<p> </p>
<p><strong>What We Offer</strong></p>
<ul>
<li>We care about ecology and are truly sustainable. Not only for the environment but also for social resources.</li>
<li>We have a highly dynamic and very international work environment.</li>
<li>We have Great Place to Work certified countries!</li>
<li>We provide a competitive salary which is adjusted on an annual basis in case of good performance.</li>
<li>We work hybrid and care about your work-life balance.</li>
<li>You will find nice extras such as various company activities during the year.</li>
</ul>
<p> </p>
<p><strong>Diversity, Equity &amp; Inclusion (DEI)</strong></p>
<p>We welcome everyone regardless of origin, gender, age, sexual orientation, philosophical or political conviction, disability etc.</p>
<p> </p>
<p> </p>


ext_id: 7766059002
published: 2025-01-22 12:07:49+00:00
title: After Sales Engineer - BU Components
location: Chicago, Illinois, United States
application_url: https://job-boards.greenhouse.io/hyva/jobs/7766059002
experience_level: MI
language: en
has_remote: False
description:
<p><strong>POSITION OVERVIEW</strong></p>
<p>The After Sales Engineer is responsible for handling technical warranty claims, complaints, problems and questions while delivering first class customer service.</p>
<p> </p>
<p><strong>MAIN TASKS AND RESPONSIBILITIES</strong></p>
<ul>
<li>Responsible for providing first class warranty handling and problem solving to our customers, so the After Sales team creates increased value for the company;</li>
<li>Handle and resolve all incoming technical warranty cases from our subsidiaries, dealers and direct customers in the warranty database within the given time parameters;</li>
<li>Work with relevant departments as part of warranty process to resolve issues;</li>
<li>Manage warranties according to Hyva’s guidelines and principles;</li>
<li>Report on After Sales statistics, trends and financials;</li>
<li>Identify root cause analysis to improve reliability, production quality and design, and follow up on these items;</li>
<li>Provide inputs to R&amp;D, Quality, Engineering, workshops on serviceability and maintainability;</li>
<li>Visit key regional personnel and dealers in conjunction with the product application/support teams to provide in depth product knowledge, including developing direct relationships with key clients;</li>
<li>Support the technical helpdesks and After Sales teams to troubleshoot technical problems;</li>
<li>Provide local technical support;</li>
<li>Define and execute field trainings for trainers, product managers and customers (country and dealer level).</li>
</ul>
<p> </p>
<p><strong>POSITION REQUIREMENTS</strong></p>
<ul>
<li><strong>Educational Level: </strong>Bachelor Level</li>
<li><strong>Professional Experience: </strong>1-3 years of relevant experience</li>
</ul>


ext_id: 7343195002
published: 2025-01-22 12:29:54+00:00
title: Customer Service Specialist
location: Chicago, Illinois, United States
application_url: https://job-boards.greenhouse.io/hyva/jobs/7343195002
experience_level: MI
language: en
has_remote: False
description:
<p><strong>POSITION OVERVIEW</strong></p>
<p>The Customer Service Specialist provides logistic, administrative and financial support for completion of sales orders and regularly communications with new and existing customers to provide sales, meet revenue targets and provide a superior level of customer satisfaction.</p>
<p><strong>MAIN TASKS AND RESPONSIBILITIES</strong></p>
<ul>
<li>Provide customer service and conduct sales with new and existing customers via telephone;</li>
<li>Support the dealers in regard to technical questions;</li>
<li>Make agreements in regard to prices and delivery conditions;</li>
<li>Create and send quotations and agreements in line with Hyva’s price policies, ensuring proper follow up;</li>
<li>Ensure correct administrative completions of sales orders, such as the processing in the ERP system;</li>
<li>Ensures correct provision of information in regard to sales orders for invoicing, taking into account particulars;</li>
<li>Monitor the delivery times and inform the customer;</li>
<li>Maintain contact with the client, such as providing product and price information;</li>
<li>Respond to complaints, ensuring provision of information to After Sales if necessary and following up on solutions;</li>
<li>Perform commercial activities focused on sales to attract new customers;</li>
<li>Maintain contact with the customers;</li>
<li>Analyze external market and competition;</li>
<li>Work in conjunction with Finance department in regard to late payments and delivery stoppage.</li>
</ul>
<p> </p>
<p><strong>POSITION REQUIREMENTS</strong></p>
<ul>
<li><strong>Educational Level:</strong> Experienced Vocational Level</li>
<li><strong>Professional Experience:</strong> Experienced Vocational Level</li>
<li><strong>Leadership Level:</strong> Individual Contributor</li>
</ul>


ext_id: 7783081002
published: 2025-01-20 10:01:53+00:00
title: General Ledger Specialist
location: Kuala Lumpur, Malaysia
application_url: https://job-boards.greenhouse.io/hyva/jobs/7783081002
experience_level: MI
language: en
has_remote: False
description:
<p></p>
<p><strong>About Us</strong></p>
<p>Hyva Group is a leading global provider of innovative and highly efficient transport solutions for the commercial vehicle and environmental service industries. The company is committed to the development, production, marketing and distribution of components used in hydraulic loading and unloading systems on trucks and trailers. Its products are used worldwide across a range of sectors including transport, construction, mining, materials handling and environmental services providers.</p>
<p>Founded in 1979, the company is headquartered in Alphen aan den Rijn in The Netherlands and operates in more than 110 countries with over 3,500 employees around the world. The Hyva Group encompasses more than 30 subsidiaries globally, with an extraordinary sales and service coverage and 14 production facilities in Brazil, China, Germany, India, and Italy, with more than 20,000 customers.</p>
<p> </p>
<p><strong>About The Role</strong></p>
<p>As a <strong>General Ledger Specialist</strong> in our brand-new <strong>Regional Hub / Shared Services Centre (SSC)</strong> in Kuala Lumpur, you will have the opportunity to play a crucial role in maintaining the financial integrity of an organization by maintaining and updating the general ledger, generating financial reporting, carrying out account reconciliation, budgeting and forecasting.</p>
<p> </p>
<p><strong>Your key responsibilities will include but not limited to:</strong></p>
<ul>
<li>Prepares journal entries, recurring and allocation journal entries, collecting adequate supporting documentation</li>
<li>Carries out month-end, quarter-end and year-end closing</li>
<li>Responsible for quarterly balance sheet, P&amp;L fluctuation analysis and monthly expense variance analysis</li>
<li>Accountable for consolidation, inter-company transactions and reconciliations including foreign currency accounting</li>
<li>Ensures accuracy of financial statements in accordance with GAAP, IFRS, local accounting policies from government and compliance to internal policies</li>
<li>Manages fixed assets, balance sheet counts reconciliation</li>
<li>Updates and maintain financial reporting on a regularly basis</li>
<li>Reports data input to group financial system on a regularly basis</li>
<li>Follows the group monthly reporting timelines and monthly closing</li>
<li>Prepares internal financial statements and domestic reports, accurately reports to senior management</li>
<li>Provides various statements and relevant auditing data for the accounting firm's audit work</li>
</ul>
<p>In this role you will be collaborating with various stakeholders across the business including our Accounting / Finance function teams in Netherlands &amp; other parts of the world.</p>
<p>Our Regional Hub supports a hybrid working approach. You will be supporting markets in multiple time zones and some flexibility around working hours will be needed.</p>
<p>You will be joining a newly formed Shared Services Centre team, with opportunities to grow, within Accounting or wider Finance functions.</p>
<p><strong>About You</strong></p>
<p><strong><em>To be successful in this role you will have:</em></strong></p>
<ul>
<li>Minimum 3 years of relevant experience</li>
<li>Proficient in full set accounts</li>
<li>Familiarity with either one of these accounting software: SAP / Oracle / Microsoft Dynamics or other similar software</li>
<li>Excellent stakeholder management and communication skills</li>
</ul>
<p><strong><em>Nice To Have</em></strong></p>
<ul>
<li>Professional membership such as ACCA / CPA / CIMA would be a big plus point</li>
<li>Regional exposure in past employment would be highly desirable, as this role requires the incumbent to deal with colleagues and stakeholders from not just Malaysia, but also Singapore, Australia, Netherlands, Germany etc</li>
</ul>
<p><strong><em>Language</em></strong></p>
<ul>
<li>Good written and spoken English is essential</li>
<li>A proficiency in Mandarin Chinese, Japanese, Korean and/or Thai as well as other Asian languages will be an added advantage, however not mandatory</li>
</ul>
<p><strong><em>Qualification / Education</em></strong></p>
<ul>
<li>Diploma / Bachelor’s Degree in Finance / Accounting or equivalent disciplines</li>
</ul>
<p><strong> </strong></p>
<p><strong>What We Offer</strong></p>
<ul>
<li>We care about ecology and are truly sustainable. Not only for the environment but also for social resources.</li>
<li>We have a highly dynamic and very international work environment.</li>
<li>We have Great Place to Work certified countries!</li>
<li>We provide a competitive salary which is adjusted on an annual basis in case of good performance.</li>
<li>We work hybrid and care about your work-life balance.</li>
<li>You will find nice extras such as various company activities during the year.</li>
</ul>
<p> </p>
<p><strong>Diversity, Equity &amp; Inclusion (DEI)</strong></p>
<p>We welcome everyone regardless of origin, gender, age, sexual orientation, philosophical or political conviction, disability etc.</p>
<p></p>


ext_id: 4382766007
published: 2025-01-22 20:26:46+00:00
title: Auditor Quality Supplier (m/w/d)
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4382766007
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Als <strong>Senior Auditor Quality Supplier (m/w/d)</strong>, in unserem neu gegründeten Quality Auditing Team führen Sie den Qualifizierungsprozess für Lieferanten durch und leiten Initiativen zum Abschluss von Anforderungsprüfungen, einschließlich Audits bei Lieferanten vor Ort. Zu den Kernaufgaben zählen die folgenden Tätigkeiten:</p>
<ul>
<li>Durchführung und Bearbeitung von Audits der Lieferantenqualitätsanforderungen sowie die Neubewertungen der Lieferanten in Zusammenarbeit mit der Abteilung QA</li>
<li>Entwicklung der Strategien und Logistik der Auditbewertung, Darlegung von Schwachstellen, unwirksame Verfahren, Ausnahmen von den Richtlinien und Unstimmigkeiten sowie Empfehlung von geeigneten Korrekturmaßnahmen</li>
<li>Bewertung der Reaktionen der Lieferanten auf Korrektur- und Vorbeugungsmaßnahmen im Zusammenhang mit Auditfeststellungen</li>
<li>Unterstützung bei der Überprüfung von Lieferantenanforderungen durch Einholung von Qualitätsanforderungen und die Erwirkung von Lösungen für Bereiche, die als Compliance-Probleme identifiziert wurden</li>
<li>Zusammenarbeit mit den Teams des Einkaufs und der Qualitätskontrolle zur Sicherstellung der Erfüllung von Lieferantenanforderungen</li>
<li>Fachexperte bei Kundenaudits, internen Audits und/oder behördlichen Inspektionen</li>
<li>Durchführung von Schulungen für andere Teammitglieder je nach Bedarf</li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Abgeschlossenes Studium im naturwissenschaftlichen Bereich oder im Ingenieurswesen mit mehrjähriger Berufserfahrung im Bereich Qualität, Herstellung oder Technik</li>
<li>Erfahrung in der Pharma-, Medizinprodukte-, Kombinationsprodukte- und/oder Biologikabranche wünschenswert</li>
<li>Erfahrung in der Auditierung von Produktionsanlagen und Laboratorien</li>
<li>EDV-Kenntnisse in Microsoft Office sowie eQMS-Software (TrackWise, JDE, Veeva usw.)</li>
<li>ASQ-, ISO- und/oder RAB-Auditoren Zulassung wünschenswert</li>
<li>Kenntnisse der pharmazeutischen Vorschriften und der internationalen Normen für die aseptische Herstellung sowie Fähigkeiten im Projektmanagement</li>
<li>Teamfähigkeit, ausgeprägte interpersonelle Fähigkeiten sowie ausgezeichnete Kommunikationsfähigkeiten in deutscher und englischer Sprache</li>
<li>Hohe Reisebereitschaft, da unsere Audits sowohl an unserem Standort in Halle (Deutschland), als auch europaweit durchgeführt werden</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Eine attraktive Vergütung und 30 Tage Urlaub</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, dass sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Lisa-Franziska Root <span>(lroot@simtra.com).</span></p>
<p>#LI-LK</p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4172806007
published: 2025-01-22 20:26:46+00:00
title: Ausbildung Chemielaborant (m/w/d), September 2025
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4172806007
experience_level: EN
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werde ein Teil des Teams und unterstütze zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Wir suchen Dich für die <strong>Ausbildung als Chemielaborant (m/w/d). </strong></p>
<p>Chemielaboranten arbeiten mit Chemikalien, Glasapparaturen und computergestützten Messgeräten. Sie führen chemische Versuche durch, in denen sie Stoffarten aufgrund ihrer chemischen und physikalischen Eigenschaften unterscheiden. Anschließend protokollieren sie gewissenhaft ihre Arbeitsabläufe und Versuchsergebnisse.</p>
<p>Die <strong>Ausbildungsdauer</strong> beträgt <strong>3,5 Jahre</strong>.</p>
<p><strong>Du bringst mit:</strong></p>
<ul>
<li>Fachoberschulreife oder allgemeine Hochschulreife (Abitur)</li>
<li>Gute Kenntnisse in den <span>naturwissenschaftlichen</span> Fächern</li>
<li>Technisches Verständnis</li>
<li>Fingerfertigkeit</li>
<li>Sorgfältige und genaue Arbeitsweise</li>
<li>Teamfähigkeit</li>
<li>EDV- und Englischkenntnisse</li>
</ul>
<p><strong>Das bieten wir Dir:</strong></p>
<p>Wenn Du hoch hinauswillst und Dich einbringen möchtest, bist Du bei uns genau richtig! Angehenden Chemielaboranten bieten wir nicht nur eine qualifizierte und fundierte Berufsausbildung, die in der Region und in der Branche einen sehr guten Ruf genießt, sondern auch folgende Vorteile:</p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Ausbildungsgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p></p>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung Deiner Unterlagen mit <strong>Anschreiben, Lebenslauf </strong>und den <strong>letzten beiden Schulzeugnissen</strong> direkt über unser Online-System.</p>
<p>Bei Rückfragen wende Dich gerne an Neil Bethge (nbethge@simtra.com).</p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4172764007
published: 2025-01-22 20:26:46+00:00
title: Ausbildung Pharmakant (m/w/d), September 2025
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4172764007
experience_level: EN
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werde ein Teil des Teams und unterstütze zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Wir suchen Dich für die <strong>Ausbildung als Pharmakant (m/w/d). </strong></p>
<p>Der Pharmakant stellt Arzneimittel aus chemischen und pflanzlichen Wirkstoffen her. Zum Einsatz kommen dabei automatisierte Produktions- und Abfüllanlagen, mit deren Hilfe sterile Lösungen, Pulver, Salben und Impfstoffe produziert werden. Pharmakanten bedienen sich dieser Maschinen, steuern und überwachen den Produktionsprozess, warten und reinigen die Arbeitsgeräte und führen Qualitätskontrollen durch. Auch die maschinelle Verpackung der Medikamente und die sachgerechte Lagerung werden von Pharmakanten übernommen. Dies sind die weiteren Ausbildungsinhalte:</p>
<ul>
<li>Pharmazeutische, chemische und physikalische Grundoperationen</li>
<li>Herstellen von sterilen Arzneimitteln</li>
<li>Mikrobiologie</li>
<li>Kontrollieren und Sichern der Qualität</li>
<li>Mess- und Regeltechnik</li>
<li>Umgang mit Arbeitsstoffen</li>
<li>Verpacken, Lagern, Disponieren</li>
<li><span>Informationstechnische</span> Arbeiten</li>
<li>Dokumentation</li>
<li><span>Arbeitssicherheit/Umweltschutz</span></li>
</ul>
<p>Die <strong>Ausbildungsdauer</strong> beträgt <strong>3,5 Jahre</strong>.</p>
<p><strong>Du bringst mit:</strong></p>
<ul>
<li>Fachoberschulreife oder allgemeine Hochschulreife (Abitur)</li>
<li>Gute Kenntnisse in den naturwissenschaftlichen Fächern</li>
<li>Technisches Verständnis</li>
<li>Fingerfertigkeit</li>
<li>Sorgfältige und genaue Arbeitsweise</li>
<li>Teamfähigkeit</li>
<li>EDV- und Englischkenntnisse</li>
</ul>
<p><strong>Das bieten wir Dir:</strong></p>
<p>Wenn Du hoch hinauswillst und Dich einbringen möchtest, bist Du bei uns genau richtig! Angehenden Pharmakanten bieten wir nicht nur eine qualifizierte und fundierte Berufsausbildung, die in der Region und in der Branche einen sehr guten Ruf genießt, sondern auch folgende Vorteile:</p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Ausbildungsgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p></p>
<p></p>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung Deiner Unterlagen mit <strong>Anschreiben, Lebenslauf </strong>und den <strong>letzten beiden Schulzeugnissen</strong> direkt über unser Online-System.</p>
<p>Bei Rückfragen wende Dich gerne an Neil Bethge (nbethge@simtra.com).</p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4609143007
published: 2025-01-22 20:26:46+00:00
title: Capping Group Leader (2nd Shift Weekend)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4609143007
experience_level: SE
language: en
has_remote: False
description:
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong> </strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</a></span></p>
<p> </p>
<p> </p>
<p> </p>
<p><strong></strong></p>
<p><strong>This role:</strong></p>
<p>The Capping Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Capping Operators who perform in the manufacturing areas.  The Capping Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Capping Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.</p>
<p><strong> </strong></p>
<p>This position is required to work all designated plant holidays.</p>
<p>2nd shift Weekends: Weekends: every Saturday/Sunday 3:00pm – 1:30am, plus 2 weekdays (either Mon/Tues or Thurs/Fri) 3:00pm – 11:30pm.</p>
<p><strong><span><span>The </span></span>responsibilities:</strong></p>
<ul>
<li>Delegate, coordinate, and schedule activities of assigned team members.</li>
<li>Train and mentor other team members.</li>
<li>Troubleshoot process problems and respond to process alarms.</li>
<li>Participate on Continuous Improvement teams.</li>
<li>Assist in developing/reviewing batch records of new and existing projects.</li>
<li>Assist in establishing and orienting new projects for production.</li>
<li>Review project plans and batch records prior to operations.</li>
<li>Monitor assigned team’s documentation in logbooks and batch records. </li>
<li>Initiate exception reports as required. </li>
<li>Organize and coordinate general cleaning and sanitizations throughout all capping suites.  Efficiently identify potential causes and verify/eliminate each one to determine the true root cause behaviors</li>
<li>Examine documents/processes (SOP’s, equipment, methods, etc.) to prevent errors and/or recognize unexpected results.</li>
<li>Required to maintain attendance in accordance with the Bloomington Attendance Policy</li>
<li>Scheduled weekend overtime will be required</li>
</ul>
<p><strong>The work environment:</strong></p>
<p>Classified pharmaceutical environment wearing required gowning as shown in attached document.  Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.</p>
<p><strong> </strong><strong>Desirable qualifications:</strong></p>
<ul>
<li>Ability to work independently</li>
<li>Good communication skills</li>
<li>Good documentation skills, including legible handwriting</li>
<li>Good interpersonal skills</li>
<li>Basic computer skills</li>
<li>Basic math skills</li>
<li>Knowledge of aseptic manufacturing practices</li>
<li>Knowledge of standard operating procedures, specifications, and job-specific training materials</li>
<li>Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices</li>
</ul>
<p><strong> </strong><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Occasional (0-33%)</li>
<li>Sitting, climbing stairs and ladders, balancing, stooping, kneeling, crouching, operating controls</li>
<li>Lifting and carrying up to 52 lbs</li>
<li>Pushing and pulling up to 22 lbs</li>
<li>Frequent (34-66%)</li>
<li>Standing, walking, reaching forward and overhead</li>
<li>Lifting and carrying up to 35 lbs</li>
<li>Pushing and pulling up to 24 lbs</li>
<li>Constant (67-100%)</li>
<li>Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</li>
</ul>
<p><strong>Additional requirement(s):</strong></p>
<ul>
<li>High school diploma or GED required</li>
<li>6 months of previous Pharmaceutical or Manufacturing experience preferred.</li>
<li>Final candidates for Capping Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</li>
</ul>
<p><strong></strong></p>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong><strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p> </p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4530087007
published: 2025-01-22 20:26:46+00:00
title: Chemielaborant (m/w/d) mit Schwerpunkt HPLC
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4530087007
experience_level: EN
language: de
has_remote: False
description:
<p></p>
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Für unser Team Qualitätskontrolle suchen wir Sie als <strong>Chemielaborant (m/w/d) mit Schwerpunkt HPLC.</strong></p>
<p>In dieser Position sind Sie verantwortlich für das GMP-gerechte Vorbereiten, Berechnen, Durchführen und Dokumentieren von Analysen nach eigenen als auch Kundenmethoden sowie den einschlägigen Pharmakopöen (Ph. Eur., USP und JP) auf dem Gebiet der HPLC. Im Einzelnen gehören zu Ihren Aufgaben:</p>
<ul>
<li>Termingerechte Bearbeitung von Prüfaufträgen gemäß Prüfvorschriften</li>
<li>Dokumentation von Analysenergebnissen</li>
<li>Durchführung von Methodentransfers und Validierungen</li>
<li>Systematische Fehleranalyse bei Geräten und Methoden</li>
<li>Erstellung von Standard-Arbeitsanweisungen und Prüfvorschriften</li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Abgeschlossene Ausbildung zum Chemielaboranten (m/w/d). Berufsanfänger sind willkommen.</li>
<li>Alternativ abgeschlossene Ausbildung zum chemisch-technischen Assistenten (m/w/d) mit einschlägigen Kenntnissen in der Flüssig-Chromatographie</li>
<li>Gute Deutsch- und Englischsprachkenntnisse in Wort und Schrift</li>
<li>Sorgfältige und gewissenhafte Arbeitsweise</li>
<li>Bereitschaft zur Arbeit im 2-Schicht-Modell</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Lisa-Franziska Root <span>(lroot@simtra.com).</span></p>
<p><span>#LI-LK</span></p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4486800007
published: 2025-01-22 20:26:46+00:00
title: Cleaning Validation Associate I
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4486800007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p><strong>This role:</strong></p>
<p>This position executes cleaning validation activities that meet global regulatory agency requirements, internal company standards/best practices and current industry practices.  This position interacts with manufacturing to develop and validate cleaning procedures, trains operators on the validated processes, and creates the Good Manufacturing Practices (GMP) documentation for validated projects to support the cleaning validation program.  This position is 100% onsite at the Bloomington facility and reports to the Sr. Manager, Cleaning Validation.</p>
<p><strong> </strong></p>
<p><strong><span><span>The </span></span>responsibilities:</strong></p>
<ul>
<li>Supports the facility equipment cleaning validation program</li>
<li>Performs carryover (i.e., product, cleaning agent, etc.) limit calculations</li>
<li>Writing and maintaining technical documentation:
<ul>
<li>Designs and executes Cleaning Validation (CV) protocols and Technical Services Studies (TSS)</li>
<li>Creates CV summaries based on data analysis from executed studies</li>
<li>Creates and maintains Standard Operating Procedures (SOPs) for cleaning validation program</li>
<li>Assembles validation packages and authors validation summaries.</li>
</ul>
</li>
<li>Conducts or coordinates Performance Qualification (PQ) execution for new products</li>
<li>Makes process improvements and modifications to the cleaning validation program, as applicable</li>
<li>Serve as Subject Matter Expert (SME) for automated/Clean-in-Place (CIP) cleaning systems</li>
<li>Performs periodic reviews of existing projects, as needed</li>
<li>Performs operator training on new process, as needed</li>
<li>Serves as liaison between Simtra and the customer</li>
<li>Participates in internal audits and client audits as cleaning validation SME</li>
<li>Change Control Management (CCM) system task owner</li>
<li>Corrective Action Preventative Action (CAPA) system owner </li>
<li>Non-Conformance Report (NCR) investigation owner</li>
</ul>
<p> </p>
<p><strong> </strong></p>
<p><strong>Required qualifications:</strong></p>
<ul>
<li>BS degree required, preferably in a science or engineering field</li>
<li>Microsoft Office (Word, Excel, and Outlook) proficiency - intermediate or higher level</li>
<li>Knowledge of enterprise software systems (i.e., SAP, Maximo, Trackwise, etc.)</li>
<li>Ability and experience working independently</li>
<li>Ability to provide critical thinking and problem-solving skills to day-to-day and project work</li>
</ul>
<p><strong> </strong></p>
<p> </p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Duties may require overtime work, nights and weekends and ability to adjust schedule, as needed</li>
<li>Position requires sitting for long hours but may involve walking or standing for periods of time</li>
<li>Able to gown for Grade C requirements</li>
</ul>
<p> </p>
<p> </p>
<p><strong>In return, you’ll be eligible for </strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4459164007
published: 2025-01-22 20:26:46+00:00
title: Commissioning & Qualification Manager
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4459164007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p><strong>This role:</strong></p>
<p>The Commissioning &amp; Qualification Manager position is responsible for ensuring production, utilities and related equipment and systems are qualified and validated in accordance with Simtra requirements, policies, and procedures.  In addition, this role is responsible for driving the effective and consistent use of the best Commissioning, Qualification, and Validation (CQV) practices used in the industry. This role provides leadership to the Engineering &amp; Technology department and to the site to ensure qualification and validation standards are being met.  This position is onsite daily at the Bloomington facility and reports to the Director of Engineering &amp; Technology. </p>
<p><strong> </strong></p>
<p><strong><span><span>The </span></span>responsibilities:</strong></p>
<ul>
<li>Accountability for activities involved in the evaluation, review and approval of validation project plans, validation protocols and reports, and other validation lifecycle documentation</li>
<li>Lead a team of full-time and contract Validation Engineers to provide guidance on planning, scheduling, and execution of validation activities</li>
<li>Provide technical &amp; tactical guidance to the validation team, completing performance management actions and regular 1:1 meetings with individuals on the team </li>
<li>Develop and evaluate quality process and system standards to ensure compliance with company standards and governmental regulatory requirements</li>
<li>Manage multiple projects/ongoing work activities within the department typically involving cross-functional teams </li>
<li>Investigate &amp; troubleshoot validation problems for equipment and/or performance processes, conducting statistical analyses of testing results and process anomalies</li>
<li>Write, review, approve and/or implement documentation for new and current validation procedures and technical reports related to equipment, products and/or processes</li>
<li>Plan and oversee the execution of validation and improvement project activities following applicable regulatory and Simtra requirements and ensure applicable Validation Master Plans (VMPs) and documents are maintained to cGxP compliance</li>
<li>Implements department strategy, by leading cross functional projects in the design or redesign of projects</li>
<li>Ensure that appropriate systems are in place such that site operations meet or exceed the requirements</li>
<li>Provide leadership to site technical staff regarding the development of validation strategies and validation master plans for equipment, facilities, utilities, and manufacturing equipment</li>
<li>Maintain all infrastructure and compliance documentation for the facility for the purpose of maintaining regulatory compliance with Contractual, Procedural, Federal, State or Local law requirements  </li>
<li>Present validation packages to boards of health/regulators &amp; internal inspections</li>
<li>Allocate department staffing and manage the utilization of facilities and equipment to ensure that department and site objectives are met within budget guidelines</li>
<li>Establish governance and contributor accountability for timely project completion</li>
<li>Develop, introduce, and review practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected regulatory standards</li>
<li>Provide leadership to vendors, staff and service providers as required to ensure that compliance expectations and adoption of best practices are communicated and followed</li>
</ul>
<p><strong> </strong></p>
<p><strong>Desirable qualifications:</strong></p>
<ul>
<li>BS degree in engineering with 5+ years (OR MS degree in engineering with 2+ years) of experience in equipment, process, utilities, or facilities commissioning, qualification, and validation within the pharmaceutical industry - in lieu of BS degree in engineering, a BS degree in a scientific discipline with 10+ years of relevant experience in in equipment, process, utilities, or facilities commissioning, qualification, and validation within the pharmaceutical industry</li>
<li>4+ years of relevant people management and leadership experience of engineers and/or scientists</li>
<li>Extensive understanding and knowledge of regulatory requirements and validation as applied to the pharmaceutical equipment and facilities</li>
<li>Good understanding of risk management methodologies, with a proven ability to apply to pharmaceutical operations</li>
<li>Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies</li>
<li>Good organizational, presentation, meeting facilitation, project/time management, and conflict resolution skills technical writing skills</li>
<li>Strong analytical and problem-solving abilities</li>
<li>Demonstrated application of cGMPs and regulatory requirements as they apply to the pharmaceutical field</li>
<li>Understanding of engineering concepts</li>
<li>Understanding of use of best practices in the life sciences industry  </li>
<li>Strong oral and written communication skills, i.e., effective presentation of concepts and ideas and technical writing skills</li>
<li>Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams) and Adobe Acrobat</li>
</ul>
<p><strong> </strong></p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Ability to obtain A/B and C/D gowning access</li>
<li>Ability to stand and walk for prolonged periods of time</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for </strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4603928007
published: 2025-01-22 20:26:46+00:00
title: Coordinator (m/w/d) Facility Services
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4603928007
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Für unser Team suchen wir Sie als <strong>Coordinator (m/w/d) Facility Services</strong><strong>.</strong></p>
<p>In dieser Position sind Sie für alle internen und externen Dienstleister im Bereich Facility Management unter kontinuierlicher Weiterentwicklung bestehender Prozesse sowie dem vollumfänglichen Gebäudeinstandhaltungs- und Standortmanagement (Außenanlagen) verantwortlich. Dies beinhaltet im Einzelnen:</p>
<ul>
<li>Koordination von interner/externer Dienstleistungen sowie administrativen Prozessen unter Zuhilfenahme elektronischer Systeme (u.a. MSD)</li>
<li>Ausschreibung und Kontrolle von Maßnahmen im Bereich Facility Services und Unterstützung des Einkaufs bei der Vergabe</li>
<li>Störungs-/Reklamations- und Instandsetzungsbearbeitung im Bereich Facility Services (Gebäudemanagement) sowie vollumfängliche Durchführung visueller Inspektionen sämtlicher Produktionsbereiche zur Erhaltung einer kontinuierlichen Audit-Readiness im Bereich Gebäudemanagement</li>
<li>Abwicklung von Kleinprojekten im Rahmen des Verantwortungsbereiches</li>
<li>Einhaltung von Richtlinien bzw. Vorschriften im Hinblick auf EHS, GMP, Qualität und gesetzliche Anforderungen</li>
<li>Vorstellung des Bereichs Facility Services in Audits in deutscher und englischer Sprache</li>
<li>Verantwortliche Betreuung des PCP (Pest Control Programm) am Standort Halle</li>
</ul>
<p><strong>Sie bringen mit: </strong></p>
<ul>
<li>Abgeschlossene technische Berufsausbildung idealerweise als Techniker (m/w/d) oder Meister (m/w/d)</li>
<li>Berufserfahrung im Bereich der Pharmaproduktion wünschenswert</li>
<li>Ausgeprägtes Verständnis für komplexe Prozesse</li>
<li>Selbstständige und strukturierte Arbeitsweise sowie eine hohe Belastbarkeit</li>
<li>Gute EDV-/Software-Kenntnisse (MS-Office)</li>
<li>Fließende Deutschkenntnisse sowie Englischkenntnisse in Wort und Schrift</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Lisa-Franziska Root <span>(lroot@simtra.com).</span></p>
<p>#LI-LK</p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4603940007
published: 2025-01-22 20:26:46+00:00
title: Coordinator (m/w/d) Maintenance Center
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4603940007
experience_level: MI
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Für unser Team suchen wir Sie als <strong>Coordinator (m/w/d) Maintenance Center</strong><strong>.</strong></p>
<p>In dieser Position sind Sie verantwortlich für die Arbeitsvorbereitung und die Qualitätskontrolle der Instandhaltungstätigkeiten von internen und externen Mitarbeitern an unserem Standort. Dies beinhaltet im Einzelnen:</p>
<ul>
<li>Koordination und Kontrolle der Instandhaltungsmaßnahmen hinsichtlich der Termintreue, der Leistungsumfänge und der Kosten</li>
<li>Entwicklung und Umsetzung von Maßnahmen zur Optimierung der Arbeitsvorbereitung</li>
<li>Prüfung sowie (Nach-)Verhandlung der Angebote mit externen Dienstleistern</li>
<li>Abbildung der prüfpflichtigen Betriebsmittel hinsichtlich Kosten, Fälligkeit und möglichen Optimierungsmaßnahmen</li>
<li>Verantwortung für die Einhaltung von Richtlinien und Vorschriften im Hinblick auf EHS, GMP, Qualität und gesetzlichen Anforderungen</li>
<li>Betreuung des Ersatzteilmanagements</li>
</ul>
<p><strong>Sie bringen mit: </strong></p>
<ul>
<li>Abgeschlossene technische Berufsausbildung idealerweise als Techniker (m/w/d) oder Meister (m/w/d)</li>
<li>Berufserfahrung im Bereich der Pharmaproduktion wünschenswert</li>
<li>Ausgeprägtes Verständnis für komplexe Prozesse</li>
<li>Selbstständige und strukturierte Arbeitsweise sowie eine hohe Belastbarkeit</li>
<li>Gute EDV-/Software-Kenntnisse (MS-Office und MS-Dynamics)</li>
<li>Fließende Deutschkenntnisse sowie Englischkenntnisse in Wort und Schrift</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<p><strong></strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p><strong></strong></p>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Selin Sencan <span>(ssencan@simtra.com).</span></p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4562883007
published: 2025-01-22 20:26:46+00:00
title: Director, Business Management
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4562883007
experience_level: EX
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p><strong>This role:</strong></p>
<p>The Director of Simtra BioPharma Solutions Business Management leads and has responsibility for the Business Management organization at our Bloomington, Indiana Contract Manufacturing location. The Business Management function leads cross functional teams in support of our B2B customers that have contracted with Simtra for delivery of  products or services.  This key leader at the site interfaces with customers throughout the project lifecycle ensuring that milestones and expectations are delivered consistently and contractual terms are followed. In this role, the Director of Business Management engages with key site and corporate functional leaders from Manufacturing, Quality, Regulatory, Technical Services, Supply Chain, Business Development, Marketing, Legal and R&amp;D in a leadership / facilitator capacity and is a member of the Senior Leadership team at the Bloomington, Indiana facility.  This individual is accountable to drive the business and service model across the functions and ensure alignment to the delivery of business results while achieving high customer satisfaction.  This person has responsibility for ensuring that the business plan is achieved for our customers products / services and that key operating principles are followed by customers to ensure a successful service experience.</p>
<p><strong>Essential Duties and Responsibilities </strong><strong>(these are primary responsibilities of the role and the incumbent will perform other duties as assigned)</strong><strong>:</strong></p>
<ul>
<li>Resource coordination across functions to meet customer delivery dates</li>
<li>Develops and implements operating mechanisms, tools, rigor and processes to the Business Management organization and functional partners</li>
<li>Develops and leads the Business Management team in project management, customer service and problem solving development</li>
<li>Participates in the selling process including proposal generation, pricing strategy and contractual negotiations</li>
<li>Facilitates customer discussions for purposes of planning, and review of executional accomplishments or shortcomings</li>
<li>Drives functional partner alignment to completion of project milestones</li>
<li>Develops and implements communication and interaction strategies with customer, site functional partners, and Simtra Executive Leadership</li>
<li>Accountable for customer demand forecasts for the monthly S&amp;OP process and Simtra’s long range plan</li>
<li>Drives enforcement of key contract provisions for both Simtra and our customers through use of metrics and analysis.</li>
<li>Drives to achieve organizational excellence in client project management by continuously developing and sustaining project management best practices and standards.</li>
<li>Accountable for achievement of Sales for products and services on a monthly and annual basis</li>
<li>Accountable to ensure contractual obligations and operating principles are achieved</li>
</ul>
<p><strong>Job Requirements (Education, Experience and Qualifications</strong><strong>):</strong></p>
<ul>
<li>Bachelor’s degree required. MBA or science-graduate degree preferred.</li>
<li>Minimum 10 years of project management experience required</li>
<li>Experience in regulated environment required.</li>
<li>Technical experience or understanding of pharmaceuticals, especially sterile injectables is preferred</li>
<li>Operations or Contract Manufacturing Experience preferred</li>
<li>Computer proficiency in Microsoft Office, Project Management Software and the ability to use enterprise software (examples include:  Microsoft Dynamics, Veeva, etc.)</li>
</ul>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4555068007
published: 2025-01-22 20:26:46+00:00
title: Director, Development and Clinical Services
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4555068007
experience_level: EX
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>The role:</strong></p>
<p>The Director of Development &amp; Clinical Services is responsible for overseeing all development and clinical activities at the site, from early-stage development through to late-phase clinical trials and regulatory approval, prior to commercial launch. This role is accountable for establishing the site’s capacity and capabilities in key areas such as lyophilization, formulation, analytical method optimization, and clinical manufacturing.</p>
<p>The incumbent will ensure the efficient and reliable clinical manufacturing throughout the entire product lifecycle, guiding projects from development through regulatory approval and into commercial operations. They will serve as the primary representative of the site’s Development and Clinical capabilities in customer interactions, ensuring strong relationships and seamless communication with clients.</p>
<p>Collaboration with the sales and marketing teams will be essential to align clinical and development strategies with broader business objectives. The Site Head will be accountable for managing the department’s budget, P&amp;L responsibilities, and the overall operational needs to drive long-term value creation.</p>
<p>As a member of the site leadership team, the Site Head is expected to uphold and exemplify the company's values and culture in all aspects of their role.</p>
<p> </p>
<p><strong>The responsibilities:</strong></p>
<ul>
<li>Lead the Development and Clinical Services business for the site.</li>
<li>Build the development and clinical capacity and capabilities including hiring, training, and team engagement.</li>
<li>Incorporate innovation and continuous improvements to deliver excellence for Simtra and the customers</li>
<li>Support and develops data acquisition and new technologies such as digital twin or enhanced DOE analysis</li>
<li>Drive the site Development and Clinical P&amp;L to achieve short-term goals and long-term value creation</li>
<li>People and organization leadership including organization design, staffing, engagement, development</li>
<li>Manage business risks, issues, dependencies</li>
<li>Deliver effective business, organization, and customer updates on a regular basis.</li>
<li>Ensure regulatory requirements and GMP standards are adhered to.</li>
<li>Oversee the change control process with customers and internal teams.</li>
<li>Identify opportunities for improvement and ensure team takes ownership and drive results.</li>
</ul>
<p><strong> </strong></p>
<p><strong>Required qualifications:</strong></p>
<ul>
<li>Bachelor’s degree in Engineering, Biotechnology, Chemistry or Biology required. PhD preferred.</li>
<li>8-10 years of experience in product development or related experience required</li>
<li>5 years of leadership experience required</li>
<li>Sound knowledge and experience in a development and/or scientific environment.</li>
<li>Customer facing experience preferred.</li>
<li>Previous P&amp;L responsibility preferred.</li>
<li>Strong business and financial acumen.</li>
<li>Experience in continuous improvement projects.</li>
<li>Innovative and strategic thinking.</li>
<li>Strong communication and interpersonal skills, able to effectively interact with and influence stakeholders at all levels.</li>
<li>Demonstrated ability to lead collaborative initiatives and promote a culture of continuous learning and excellence.</li>
<li>Computer proficiency in Microsoft Project, Word, Excel, and Outlook and the ability to use enterprise software tools.</li>
<li>Strong preference for candidates to be local to site of responsibility.</li>
</ul>
<p><strong> </strong></p>
<p><strong>Physical Requirements</strong></p>
<ul>
<li>Duties may require overtime work, including nights and weekends.</li>
<li>Position requires sitting for long hours but may involve walking or standing for periods of time.</li>
<li>Use of hands and fingers to manipulate office equipment</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4599313007
published: 2025-01-22 20:26:46+00:00
title: Director of Technical Support, Development & Clinical Services
location: Remote - US
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4599313007
experience_level: EX
language: en
has_remote: True
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p>The <em>Director Technical Support, Development &amp; Clinical Services</em> acts as a key technical interface between Simtra's customers and both our commercial and development service teams. This role supports Account Management and Business Development in promoting Simtra's development service capabilities, helping to secure new projects. The Director Technical Support will collaborate closely with the Technical Support team, the development service teams and business operations to craft tailored service proposals that not only meet but exceed client expectations and requirements.</p>
<p> </p>
<p><strong>What you’ll do:</strong></p>
<ul>
<li>Consult customers on Simtra's capabilities related to</li>
<ul>
<li>Drug product formulation development</li>
<li>Compatibility studies drug formulation – container closure system</li>
<li>Analytical method development and transfer</li>
<li>Lyophilisation cycle development and optimization</li>
<li>Process development, optimization, qualification and validation</li>
<li>Clinical batch production</li>
<li>Scale -up GMP batches</li>
<li>Antibody-drug conjugates (ADC) C&amp;P and F/F processes</li>
</ul>
<li>Serve as the technical interface between the customer and Simtra's Commercial and Development Services team:</li>
<ul>
<li>Be an active part of the account team and support the development and execution of specific account plans.</li>
<li>Build and maintain strong relationships with customers and mapping their decision-making processes.</li>
<li>Explore customer pipeline strategies and industry trends, sharing insights with relevant stakeholders.</li>
<li>Proactively support the development and execution of commercial strategies for Development Services.</li>
<li>Implement Simtra's Development Service strategy to ensure strong, day-to-day customer relationships.</li>
<li>Interface with customers and account managers to gather background information and technical requirements for customer projects.</li>
<li>Act as liaison between Account Manager/ Business Development Executives and Development Service teams to translate customer requirements into appropriate proposals and support the acquisition of new development projects.</li>
<li>Prepare technical presentations to position Simtra's services based on customer needs and evolving industry trends.</li>
<li>Represent Simtra at tradeshows, conferences, technical seminars, and webinars.</li>
</ul>
<li>Maintain ongoing customer support throughout the project lifecycle, ensuring customer needs are continually met, addressing technical inquiries, and fostering long-term relationships for customer retention.</li>
<li>Provide technical troubleshooting and problem-solving expertise to address challenges encountered by customers during development and ensure successful project outcomes.</li>
<li>Conduct training sessions and workshops for customers and internal teams to ensure understanding and optimal use of Simtra's technical solutions and capabilities.</li>
<li>Lead and mentor the Technical Support team, providing guidance, training, and development opportunities to build high-performing teams capable of delivering exceptional results and driving customer satisfaction.</li>
<li>Represent Simtra as a thought leader in the industry, participating in high-profile conferences, trade shows, and webinars to enhance the company’s visibility and reputation.</li>
</ul>
<p><strong> </strong></p>
<p><strong>Basic Qualifications:</strong> </p>
<ul>
<li>Bachelor’s degree in Pharmacy, Biochemistry, Chemistry, Biology, or a related technical field; Advanced degree in Pharmacy, Biochemistry, Chemistry, Biology, or related technical field preferred; equivalent leadership experience in the pharmaceutical industry will also be considered.</li>
<li>8-10 years of experience in the pharmaceutical industry or service provider environment, with significant leadership in antibody-drug conjugates (ADC) development, manufacturing, or pharmaceutical drug development.</li>
<li>8-10 years of experience in technical support, technical business development, or drug product development, with a proven track record of leading cross-functional teams, driving strategic initiatives, and delivering client-focused solutions.</li>
</ul>
<p><strong> </strong></p>
<p><strong>Preferred Knowledge, Skills and Abilities:</strong></p>
<ul>
<li>Leadership &amp; Team Management: Proven experience managing and mentoring high-performing teams in a global, virtual environment.</li>
<li>Strategic Vision: Ability to develop and execute long-term strategic plans that align with company goals and drive business growth.</li>
<li>Stakeholder Management: Experience in engaging with C-suite executives, regulatory authorities, and key industry stakeholders to influence decision-making.</li>
<li>Demonstrated ability to think strategically and align solutions with client needs and business objectives.</li>
<li>Ability to work autonomously in a fast-paced and complex environment, demonstrating adaptability and a self-motivated work ethic.</li>
<li>Proven ability to manage multiple priorities with a sense of urgency and drive successful outcomes.</li>
<li>Ability to quickly comprehend and effectively communicate complex, technical information, translating it into clear business solutions for clients.</li>
<li>Exceptional interpersonal skills, with a proven ability to build rapport, influence stakeholders, and manage key relationships across organizational levels, business units, and clients.</li>
<li>Proven ability to proactively anticipate and identify client needs, making tailored recommendations that drive value.</li>
<li>Ability to thrive in a virtual, global environment, collaborating effectively across different time zones and cultures.</li>
<li>Excellent English language skills (written/oral), additional languages preferred.</li>
</ul>
<p> </p>
<p><strong>Travel Requirements:</strong></p>
<ul>
<li>Must be able to travel up to 25% of the time, including internationally</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4297997007
published: 2025-01-22 20:26:46+00:00
title: Engineering Manager, Biopharma Systems
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4297997007
experience_level: MI
language: en
has_remote: False
description:
<p></p>
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p>We are seeking a highly skilled and experienced Engineering &amp; Technology (Biopharma Sytems) Manager to join our pharmaceutical manufacturing company. The ideal candidate will be responsible for overseeing all engineering and technology aspects of our manufacturing operations, ensuring the efficiency, safety, and compliance of our production processes.</p>
<p> </p>
<p><strong>The responsibilities:</strong></p>
<ul>
<li>Lead and manage a team of engineers and technologists to support manufacturing operations and projects.</li>
<li>Lead the engineering evaluations of manufacturing, critical utilities, facilities and plant equipment to optimize performance and ensure timely lifecycle investments in this equipment.</li>
<li>Provide guidance and train maintenance and line engineers on proper care and operation of this equipment.</li>
<li>Develop and implement engineering strategies to optimize manufacturing processes and improve productivity.</li>
<li>Ensure compliance with regulatory requirements and industry standards related to pharmaceutical manufacturing.</li>
<li>Identify opportunities for process improvement and innovation within the manufacturing environment.</li>
<li>Identify, evaluate and implement improvements in energy supply, generation, usage and distribution.</li>
<li>Collaborate with cross-functional teams, including Research &amp; Development, Quality Assurance, and Operations, to align engineering and technology initiatives with overall company goals.</li>
<li>Manage engineering projects from conception to completion, including budgeting, resource allocation, and timeline management.]</li>
<li>Implement new technologies, controls, and automation systems to enhance manufacturing efficiency and quality.</li>
<li>Conduct risk assessments and implement risk mitigation strategies for engineering projects.</li>
<li>Foster a culture of continuous learning and development within the engineering team.</li>
<li>Build and maintain relationships with external vendors and suppliers to source equipment, materials, and services for engineering projects.</li>
</ul>
<p> </p>
<p><strong>Desirable qualifications:</strong></p>
<ul>
<li>Bachelor’s degree in engineering or a related field; advanced degree preferred.</li>
<li>3–5 years proven experience in engineering and technology management within the pharmaceutical or manufacturing industry.</li>
<li>Strong knowledge of pharmaceutical manufacturing processes, regulations, and best practices.</li>
<li>Excellent leadership and team management skills.</li>
<li>Demonstrated ability to drive process improvement and innovation.</li>
<li>Exceptional project management and problem-solving skills.</li>
<li>Effective communication and collaboration skills.</li>
<li>Ability to work in a fast-paced and dynamic environment.</li>
</ul>
<p></p>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p></p>
<p></p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4607900007
published: 2025-01-22 20:26:46+00:00
title: Filling Group Leader (3rd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4607900007
experience_level: SE
language: en
has_remote: False
description:
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong> </strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</a></span></p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p>The Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas.  The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. </p>
<p><strong> </strong></p>
<p><strong>The responsibilities:</strong></p>
<ul>
<li>Delegate, coordinate, and schedule activities of assigned team members.</li>
<li>Recommend measures to improve performance and increase efficiency</li>
<li>Train and mentor other team members.</li>
<li>Troubleshoot process problems and respond to process alarms.</li>
<li>Participate on Continuous Improvement teams.</li>
<li>Assist in developing/reviewing batch records of new and existing projects.</li>
<li>Assist in establishing and orienting new projects for production</li>
<li>Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.  </li>
<li>Organize and coordinate general cleaning and sanitizations throughout all filling suites.</li>
<li>Identify potential causes and verify/eliminate each one to determine the true root cause behavior</li>
<li>Required to maintain attendance in accordance with the Bloomington Attendance Policy</li>
<li>Scheduled weekend overtime will be required</li>
</ul>
<p><strong>The work environment:</strong></p>
<p>Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space. <strong> </strong></p>
<p><strong>Desirable qualifications:</strong></p>
<p>To<span> perform this job successfully an individual must be able to perform each essential duty satisfactorily</span><span>.  </span><span>The requirements listed below are representative of the knowledge, skill, and/or ability required</span><span>.  </span><span>Reasonable accommodations may be made to enable individuals to perform the essential functions:</span><span> </span></p>
<ul>
<li><span><span> Ability to work independently</span></span></li>
<li><span><span> Good communication skills</span></span></li>
<li><span><span> Good documentation skills, including legible handwriting</span></span></li>
<li><span><span> Good interpersonal skills</span></span></li>
<li><span><span> Basic computer skills</span></span></li>
<li><span><span> Basic math skills</span></span></li>
<li><span><span> Knowledge of aseptic manufacturing practices</span></span>
<ul>
<li>Knowledge of standard operating procedures, specifications, and job-specific training materials<span>/</span><span>Subject Matter Expert</span></li>
<li>Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices</li>
</ul>
</li>
</ul>
<p><strong> </strong></p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Occasional<span> (</span><span>1</span><span>-33%)</span>
<ul>
<li><span><span> Sitting, climbing stairs and ladders, balancing, kneeling, operating controls</span></span></li>
<li><span><span> Lifting and carrying up to 70 lbs</span></span></li>
<li><span><span> Pushing and pulling up to 35 lbs</span></span></li>
</ul>
</li>
<li><span><span> Frequent (34-66%)</span></span>
<ul>
<li><span><span> Standing, walking, reaching forward and overhead, stooping, crouching, </span></span></li>
<li><span><span> Lifting and carrying up to 37 lbs</span></span></li>
</ul>
</li>
<li><span><span> Constant (67-100%)</span></span>
<ul>
<li><span><span> Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</span></span></li>
</ul>
</li>
</ul>
<p><span> </span></p>
<p><strong>Additional requirement(s):</strong></p>
<ul>
<li>High school diploma or GED required</li>
<li>6 months of previous Pharmaceutical or Manufacturing experience preferred.</li>
<li>Final candidates for Capping Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong><strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p> </p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4588022007
published: 2025-01-22 20:26:46+00:00
title: Filling Operator (1st Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4588022007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p> </p>
<p><strong>Why join Team Simtra? Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p>.</p>
<p> </p>
<p><strong>This role:</strong></p>
<p><span>The Filling Operator (Operator III) position is responsible for aseptic execution of assigned activities within the Grade A/B manufacturing area; activities shall include current Good Manufacturing Practices (cGMP) compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and fill machine equipment, and conformance to Good Documentation Practices (GDP) standards. A Filling Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures.  This Filling Operator may be required to cross-train as a support Operator for additional areas.  This position reports to a Manufacturing Supervisor.</span><span> </span></p>
<p> </p>
<p><strong><span><span>The responsibilities</span><span>:</span></span><span> </span></strong></p>
<ul>
<li><span>Understand and follow current Good Manufacturing Practices</span><span> </span></li>
<li><span>Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade A/B work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule. </span><span> </span></li>
<li><span>May be required to cross train as a support operator to assist additional manufacturing areas.</span><span> </span></li>
<li><span>Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.</span><span> </span></li>
<li><span>Perform routine verification of equipment when unloading autoclaves and setting up aseptic filling machines.  </span><span> </span></li>
<li><span>Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality (SISPQ) impact to the batch.    </span><span> </span></li>
<li><span>Perform routine operations utilizing aseptic formulation and filling equipment in Grade A/B areas. </span><span> </span></li>
<li><span>Perform environmental monitoring; including fingertip, contact, and fallout plates.</span><span> </span></li>
<li><span><span>Assist</span><span> in the training and development of other team members</span></span><span> </span></li>
<li><span><span>Required to </span><span>maintain</span><span> attendance </span><span>in accordance with</span><span> the Bloomington Attendance Policy</span></span><span> </span></li>
<li><span><span>Scheduled weekend o</span><span>vertime will be </span><span>required</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>The work environment</span><span>:  </span></span></strong></p>
<p><span><span>Classified</span><span> pharmaceutical environment wearing required gowning</span><span>. Must</span><span> be able to work safely with materials </span><span>required</span><span> to produce pharmaceutical products, including chemicals, compounds, </span><span>glassware</span><span> and sanitization solutions</span><span>.</span><span>  </span><span>Must be able to occasionally (1-33% of the time) work in a confined/clustered </span><span>work space</span><span>.</span></span><span> </span></p>
<p> </p>
<p><strong><span><span>Desirable qualifications</span><span>:</span></span><span><span>  </span></span></strong></p>
<p><span><span>To</span><span> perform this job successfully an individual must be able to perform each essential duty satisfactorily</span><span>.  </span><span>The requirements listed below are representative of the knowledge, skill, and/or ability required</span><span>.  </span><span>Reasonable accommodations may be made to enable individuals to perform the essential functions:</span></span><span> </span></p>
<ul>
<li><span><span>Ability to work independently</span></span><span> </span></li>
<li><span><span>Good communication</span><span> skills</span></span><span> </span></li>
<li><span><span>Good documentation skills, including legible handwriting</span></span><span> </span></li>
<li><span><span>Good interpersonal skills</span></span><span> </span></li>
<li><span><span>Basic</span><span> computer skills</span></span><span> </span></li>
<li><span><span>Basic math skills</span></span><span> </span></li>
<li><span><span>Knowledge of aseptic manufacturing practices</span></span><span> </span></li>
<li><span><span>Knowledge of standard operating procedures, specifications, and job-specific training </span><span>materials</span></span><span> </span></li>
<li><span><span>Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>Physical / safety requirements:</span></span></strong></p>
<ul>
<li><span><span>Occasional</span><span> (</span><span>1</span><span>-33%)</span></span>
<ul>
<li><span>Sitting</span><span>, </span><span>climbing stairs</span><span> and</span><span> ladders, balancing, kneeling, operating control</span><span>s</span></li>
<li><span>Lifting and carrying </span><span>up to </span><span>70 </span><span>lbs</span></li>
<li><span>Push</span><span>ing</span><span> and pull</span><span>ing</span><span> up to </span><span>35</span> <span>lbs</span></li>
</ul>
</li>
<li><span>Frequent </span><span>(34-66%)</span>
<ul>
<li><span>Standing, walking, reaching forward and overhead, sto</span><span>o</span><span>ping, crouching, </span></li>
<li><span>Lift</span><span>ing</span><span> and carry</span><span>ing</span><span> up to </span><span>37</span> <span>lbs</span></li>
</ul>
</li>
<li><span>Constant</span><span> (67-100</span><span>%</span><span>)</span>
<ul>
<li><span>Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</span><span> </span></li>
</ul>
</li>
<li><span><span>Final</span><span> candidates for </span><span>Filling</span><span> Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</span></span><span> </span></li>
</ul>
<p> </p>
<p> </p>
<p><strong><span><span>Additional requirements:</span></span></strong></p>
<ul>
<li><span><span>Education and experience -</span></span><span><span> </span><span>High</span><span> School diploma or GED </span><span>required</span><span>, 6 months of </span><span>previous</span><span> Pharmaceutical </span><span>or Manufacturing experience preferred.</span></span></li>
<li><span><span>Language skills -</span></span><span><span> must be able to understand, speak, </span><span>read</span><span> and write English </span><span>in order to</span> <span>comply with</span><span> necessary SOP</span><span>’,</span><span> job-specific training materials, GMP’s, and other manuals.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>


ext_id: 4526214007
published: 2025-01-22 20:26:46+00:00
title: Filling Operator (1st Shift Weekend)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4526214007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p> </p>
<p><strong>Why join Team Simtra? Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p>.</p>
<p> </p>
<p><strong>This role:</strong></p>
<p><span>The Filling Operator (Operator III) position is responsible for aseptic execution of assigned activities within the Grade A/B manufacturing area; activities shall include current Good Manufacturing Practices (cGMP) compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and fill machine equipment, and conformance to Good Documentation Practices (GDP) standards. A Filling Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures.  This Filling Operator may be required to cross-train as a support Operator for additional areas.  This position reports to a Manufacturing Supervisor.</span><span> </span></p>
<p><span></span></p>
<p>This position is required to work all designated plant holidays.</p>
<p>1st shift, Weekends: Saturday/Sunday 7:00am – 5:30am, plus 2 weekdays (either Mon/Tues or Thurs/Fri) 7:00am – 3:30pm. </p>
<p><span></span></p>
<p> </p>
<p><strong><span><span>The responsibilities</span><span>:</span></span><span> </span></strong></p>
<ul>
<li><span>Understand and follow current Good Manufacturing Practices</span><span> </span></li>
<li><span>Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade A/B work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule. </span><span> </span></li>
<li><span>May be required to cross train as a support operator to assist additional manufacturing areas.</span><span> </span></li>
<li><span>Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.</span><span> </span></li>
<li><span>Perform routine verification of equipment when unloading autoclaves and setting up aseptic filling machines.  </span><span> </span></li>
<li><span>Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality (SISPQ) impact to the batch.    </span><span> </span></li>
<li><span>Perform routine operations utilizing aseptic formulation and filling equipment in Grade A/B areas. </span><span> </span></li>
<li><span>Perform environmental monitoring; including fingertip, contact, and fallout plates.</span><span> </span></li>
<li><span><span>Assist</span><span> in the training and development of other team members</span></span><span> </span></li>
<li><span><span>Required to </span><span>maintain</span><span> attendance </span><span>in accordance with</span><span> the Bloomington Attendance Policy</span></span><span> </span></li>
<li><span><span>Scheduled weekend o</span><span>vertime will be </span><span>required</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>The work environment</span><span>:  </span></span></strong></p>
<p><span><span>Classified</span><span> pharmaceutical environment wearing required gowning</span><span>. Must</span><span> be able to work safely with materials </span><span>required</span><span> to produce pharmaceutical products, including chemicals, compounds, </span><span>glassware</span><span> and sanitization solutions</span><span>.</span><span>  </span><span>Must be able to occasionally (1-33% of the time) work in a confined/clustered </span><span>work space</span><span>.</span></span><span> </span></p>
<p> </p>
<p><strong><span><span>Desirable qualifications</span><span>:</span></span><span><span>  </span></span></strong></p>
<p><span><span>To</span><span> perform this job successfully an individual must be able to perform each essential duty satisfactorily</span><span>.  </span><span>The requirements listed below are representative of the knowledge, skill, and/or ability required</span><span>.  </span><span>Reasonable accommodations may be made to enable individuals to perform the essential functions:</span></span><span> </span></p>
<ul>
<li><span><span>Ability to work independently</span></span><span> </span></li>
<li><span><span>Good communication</span><span> skills</span></span><span> </span></li>
<li><span><span>Good documentation skills, including legible handwriting</span></span><span> </span></li>
<li><span><span>Good interpersonal skills</span></span><span> </span></li>
<li><span><span>Basic</span><span> computer skills</span></span><span> </span></li>
<li><span><span>Basic math skills</span></span><span> </span></li>
<li><span><span>Knowledge of aseptic manufacturing practices</span></span><span> </span></li>
<li><span><span>Knowledge of standard operating procedures, specifications, and job-specific training </span><span>materials</span></span><span> </span></li>
<li><span><span>Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>Physical / safety requirements:</span></span></strong></p>
<ul>
<li><span><span>Occasional</span><span> (</span><span>1</span><span>-33%)</span></span>
<ul>
<li><span>Sitting</span><span>, </span><span>climbing stairs</span><span> and</span><span> ladders, balancing, kneeling, operating control</span><span>s</span></li>
<li><span>Lifting and carrying </span><span>up to </span><span>70 </span><span>lbs</span></li>
<li><span>Push</span><span>ing</span><span> and pull</span><span>ing</span><span> up to </span><span>35</span> <span>lbs</span></li>
</ul>
</li>
<li><span>Frequent </span><span>(34-66%)</span>
<ul>
<li><span>Standing, walking, reaching forward and overhead, sto</span><span>o</span><span>ping, crouching, </span></li>
<li><span>Lift</span><span>ing</span><span> and carry</span><span>ing</span><span> up to </span><span>37</span> <span>lbs</span></li>
</ul>
</li>
<li><span>Constant</span><span> (67-100</span><span>%</span><span>)</span>
<ul>
<li><span>Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</span><span> </span></li>
</ul>
</li>
<li><span><span>Final</span><span> candidates for </span><span>Filling</span><span> Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</span></span><span> </span></li>
</ul>
<p> </p>
<p> </p>
<p><strong><span><span>Additional requirements:</span></span></strong></p>
<ul>
<li><span><span>Education and experience -</span></span><span><span> </span><span>High</span><span> School diploma or GED </span><span>required</span><span>, 6 months of </span><span>previous</span><span> Pharmaceutical </span><span>or Manufacturing experience preferred.</span></span></li>
<li><span><span>Language skills -</span></span><span><span> must be able to understand, speak, </span><span>read</span><span> and write English </span><span>in order to</span> <span>comply with</span><span> necessary SOP</span><span>’,</span><span> job-specific training materials, GMP’s, and other manuals.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>


ext_id: 4609198007
published: 2025-01-22 20:26:46+00:00
expired: 2025-01-25 17:22:57+00:00
title: Filling Operator (2nd Shift - Weekends)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4609198007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p> </p>
<p><strong>Why join Team Simtra? Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p>.</p>
<p> </p>
<p><strong>This role:</strong></p>
<p><span>The Filling Operator (Operator III) position is responsible for aseptic execution of assigned activities within the Grade A/B manufacturing area; activities shall include current Good Manufacturing Practices (cGMP) compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and fill machine equipment, and conformance to Good Documentation Practices (GDP) standards. A Filling Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures.  This Filling Operator may be required to cross-train as a support Operator for additional areas.  This position reports to a Manufacturing Supervisor.</span><span> </span></p>
<p>This position is required to work all designated plant holidays.</p>
<p>1st shift Weekends: Weekends: every Saturday/Sunday 7:00am- 5:30pm, plus 2 weekdays (either Mon/Tues or Thurs/Fri) 7:00am- 3:30pm.</p>
<p><strong><span><span>The responsibilities</span><span>:</span></span><span> </span></strong></p>
<ul>
<li><span>Understand and follow current Good Manufacturing Practices</span><span> </span></li>
<li><span>Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade A/B work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule. </span><span> </span></li>
<li><span>May be required to cross train as a support operator to assist additional manufacturing areas.</span><span> </span></li>
<li><span>Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.</span><span> </span></li>
<li><span>Perform routine verification of equipment when unloading autoclaves and setting up aseptic filling machines.  </span><span> </span></li>
<li><span>Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality (SISPQ) impact to the batch.    </span><span> </span></li>
<li><span>Perform routine operations utilizing aseptic formulation and filling equipment in Grade A/B areas. </span><span> </span></li>
<li><span>Perform environmental monitoring; including fingertip, contact, and fallout plates.</span><span> </span></li>
<li><span><span>Assist</span><span> in the training and development of other team members</span></span><span> </span></li>
<li><span><span>Required to </span><span>maintain</span><span> attendance </span><span>in accordance with</span><span> the Bloomington Attendance Policy</span></span><span> </span></li>
<li><span><span>Scheduled weekend o</span><span>vertime will be </span><span>required</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>The work environment</span><span>:  </span></span></strong></p>
<p><span><span>Classified</span><span> pharmaceutical environment wearing required gowning</span><span>. Must</span><span> be able to work safely with materials </span><span>required</span><span> to produce pharmaceutical products, including chemicals, compounds, </span><span>glassware</span><span> and sanitization solutions</span><span>.</span><span>  </span><span>Must be able to occasionally (1-33% of the time) work in a confined/clustered </span><span>work space</span><span>.</span></span><span> </span></p>
<p> </p>
<p><strong><span><span>Desirable qualifications</span><span>:</span></span><span><span>  </span></span></strong></p>
<p><span><span>To</span><span> perform this job successfully an individual must be able to perform each essential duty satisfactorily</span><span>.  </span><span>The requirements listed below are representative of the knowledge, skill, and/or ability required</span><span>.  </span><span>Reasonable accommodations may be made to enable individuals to perform the essential functions:</span></span><span> </span></p>
<ul>
<li><span><span>Ability to work independently</span></span><span> </span></li>
<li><span><span>Good communication</span><span> skills</span></span><span> </span></li>
<li><span><span>Good documentation skills, including legible handwriting</span></span><span> </span></li>
<li><span><span>Good interpersonal skills</span></span><span> </span></li>
<li><span><span>Basic</span><span> computer skills</span></span><span> </span></li>
<li><span><span>Basic math skills</span></span><span> </span></li>
<li><span><span>Knowledge of aseptic manufacturing practices</span></span><span> </span></li>
<li><span><span>Knowledge of standard operating procedures, specifications, and job-specific training </span><span>materials</span></span><span> </span></li>
<li><span><span>Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>Physical / safety requirements:</span></span></strong></p>
<ul>
<li><span><span>Occasional</span><span> (</span><span>1</span><span>-33%)</span></span>
<ul>
<li><span>Sitting</span><span>, </span><span>climbing stairs</span><span> and</span><span> ladders, balancing, kneeling, operating control</span><span>s</span></li>
<li><span>Lifting and carrying </span><span>up to </span><span>70 </span><span>lbs</span></li>
<li><span>Push</span><span>ing</span><span> and pull</span><span>ing</span><span> up to </span><span>35</span> <span>lbs</span></li>
</ul>
</li>
<li><span>Frequent </span><span>(34-66%)</span>
<ul>
<li><span>Standing, walking, reaching forward and overhead, sto</span><span>o</span><span>ping, crouching, </span></li>
<li><span>Lift</span><span>ing</span><span> and carry</span><span>ing</span><span> up to </span><span>37</span> <span>lbs</span></li>
</ul>
</li>
<li><span>Constant</span><span> (67-100</span><span>%</span><span>)</span>
<ul>
<li><span>Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</span><span> </span></li>
</ul>
</li>
<li><span><span>Final</span><span> candidates for </span><span>Filling</span><span> Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</span></span><span> </span></li>
</ul>
<p> </p>
<p> </p>
<p><strong><span><span>Additional requirements:</span></span></strong></p>
<ul>
<li><span><span>Education and experience -</span></span><span><span> </span><span>High</span><span> School diploma or GED </span><span>required</span><span>, 6 months of </span><span>previous</span><span> Pharmaceutical </span><span>or Manufacturing experience preferred.</span></span></li>
<li><span><span>Language skills -</span></span><span><span> must be able to understand, speak, </span><span>read</span><span> and write English </span><span>in order to</span> <span>comply with</span><span> necessary SOP</span><span>’,</span><span> job-specific training materials, GMP’s, and other manuals.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong><strong>:</strong></p>
<ul>
<li>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p> </p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>


ext_id: 4588364007
published: 2025-01-22 20:26:46+00:00
title: Filling Operator (3rd Shift Weekend)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4588364007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p> </p>
<p><strong>Why join Team Simtra? Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p>.</p>
<p> </p>
<p><strong>This role:</strong></p>
<p><span>The Filling Operator (Operator III) position is responsible for aseptic execution of assigned activities within the Grade A/B manufacturing area; activities shall include current Good Manufacturing Practices (cGMP) compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and fill machine equipment, and conformance to Good Documentation Practices (GDP) standards. A Filling Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures.  This Filling Operator may be required to cross-train as a support Operator for additional areas.  This position reports to a Manufacturing Supervisor.</span><span> </span></p>
<p></p>
<p>This position is required to work all designated plant holidays.</p>
<p>3rd shift Weekends: every Saturday/Sunday 11pm – 9:30am, plus 2 weekdays (either Mon/Tues or Thurs/Fri) 11pm – 7:30am. </p>
<p></p>
<p><strong><span><span>The responsibilities</span><span>:</span></span><span> </span></strong></p>
<ul>
<li><span>Understand and follow current Good Manufacturing Practices</span><span> </span></li>
<li><span>Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade A/B work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule. </span><span> </span></li>
<li><span>May be required to cross train as a support operator to assist additional manufacturing areas.</span><span> </span></li>
<li><span>Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.</span><span> </span></li>
<li><span>Perform routine verification of equipment when unloading autoclaves and setting up aseptic filling machines.  </span><span> </span></li>
<li><span>Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality (SISPQ) impact to the batch.    </span><span> </span></li>
<li><span>Perform routine operations utilizing aseptic formulation and filling equipment in Grade A/B areas. </span><span> </span></li>
<li><span>Perform environmental monitoring; including fingertip, contact, and fallout plates.</span><span> </span></li>
<li><span><span>Assist</span><span> in the training and development of other team members</span></span><span> </span></li>
<li><span><span>Required to </span><span>maintain</span><span> attendance </span><span>in accordance with</span><span> the Bloomington Attendance Policy</span></span><span> </span></li>
<li><span><span>Scheduled weekend o</span><span>vertime will be </span><span>required</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>The work environment</span><span>:  </span></span></strong></p>
<p><span><span>Classified</span><span> pharmaceutical environment wearing required gowning</span><span>. Must</span><span> be able to work safely with materials </span><span>required</span><span> to produce pharmaceutical products, including chemicals, compounds, </span><span>glassware</span><span> and sanitization solutions</span><span>.</span><span>  </span><span>Must be able to occasionally (1-33% of the time) work in a confined/clustered </span><span>work space</span><span>.</span></span><span> </span></p>
<p> </p>
<p><strong><span><span>Desirable qualifications</span><span>:</span></span><span><span>  </span></span></strong></p>
<p><span><span>To</span><span> perform this job successfully an individual must be able to perform each essential duty satisfactorily</span><span>.  </span><span>The requirements listed below are representative of the knowledge, skill, and/or ability required</span><span>.  </span><span>Reasonable accommodations may be made to enable individuals to perform the essential functions:</span></span><span> </span></p>
<ul>
<li><span><span>Ability to work independently</span></span><span> </span></li>
<li><span><span>Good communication</span><span> skills</span></span><span> </span></li>
<li><span><span>Good documentation skills, including legible handwriting</span></span><span> </span></li>
<li><span><span>Good interpersonal skills</span></span><span> </span></li>
<li><span><span>Basic</span><span> computer skills</span></span><span> </span></li>
<li><span><span>Basic math skills</span></span><span> </span></li>
<li><span><span>Knowledge of aseptic manufacturing practices</span></span><span> </span></li>
<li><span><span>Knowledge of standard operating procedures, specifications, and job-specific training </span><span>materials</span></span><span> </span></li>
<li><span><span>Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>Physical / safety requirements:</span></span></strong></p>
<ul>
<li><span><span>Occasional</span><span> (</span><span>1</span><span>-33%)</span></span>
<ul>
<li><span>Sitting</span><span>, </span><span>climbing stairs</span><span> and</span><span> ladders, balancing, kneeling, operating control</span><span>s</span></li>
<li><span>Lifting and carrying </span><span>up to </span><span>70 </span><span>lbs</span></li>
<li><span>Push</span><span>ing</span><span> and pull</span><span>ing</span><span> up to </span><span>35</span> <span>lbs</span></li>
</ul>
</li>
<li><span>Frequent </span><span>(34-66%)</span>
<ul>
<li><span>Standing, walking, reaching forward and overhead, sto</span><span>o</span><span>ping, crouching, </span></li>
<li><span>Lift</span><span>ing</span><span> and carry</span><span>ing</span><span> up to </span><span>37</span> <span>lbs</span></li>
</ul>
</li>
<li><span>Constant</span><span> (67-100</span><span>%</span><span>)</span>
<ul>
<li><span>Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</span><span> </span></li>
</ul>
</li>
<li><span><span>Final</span><span> candidates for </span><span>Filling</span><span> Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</span></span><span> </span></li>
</ul>
<p> </p>
<p> </p>
<p><strong><span><span>Additional requirements:</span></span></strong></p>
<ul>
<li><span><span>Education and experience -</span></span><span><span> </span><span>High</span><span> School diploma or GED </span><span>required</span><span>, 6 months of </span><span>previous</span><span> Pharmaceutical </span><span>or Manufacturing experience preferred.</span></span></li>
<li><span><span>Language skills -</span></span><span><span> must be able to understand, speak, </span><span>read</span><span> and write English </span><span>in order to</span> <span>comply with</span><span> necessary SOP</span><span>’,</span><span> job-specific training materials, GMP’s, and other manuals.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>


ext_id: 4613846007
published: 2025-01-22 20:26:46+00:00
title: Finishing Group Leader (1st Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4613846007
experience_level: SE
language: en
has_remote: False
description:
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong> </strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</a></span></p>
<p> </p>
<p> </p>
<p> </p>
<p><strong></strong></p>
<p><strong>This role:</strong></p>
<p>The Finishing Production Group Leader provides leadership, coaching and communication on an individual and group basis to meet client demand and expectations. The Group Leader contributes to creating an environment where teamwork, productivity, Safety, Identity, Strength, Purity and Quality (SISPQ) are reflected in the finished product. This position reports to a Manufacturing Supervisor.</p>
<p><strong> </strong><strong><span><span>The </span></span>responsibilities:</strong></p>
<ul>
<li>Production Operations Monitoring &amp; Execution</li>
<li>Communicate process/equipment delays to appropriate levels of management as well as subsequent shifts</li>
<li>Work with Sr. Technicians to improve line performance (uptime and efficiency)</li>
<li>Manage TOR (Time out of refrigeration) for refrigerated product</li>
<li>Coordinate material delivery and pick-up with Warehouse and Label Control personnel</li>
<li>Manage electronic inventory transactions at the time of activity completion</li>
<li>Coordinate with Technical Services and Engineering to process Technical and Qualification studies, respectively</li>
<li>Monitor and ensure batch record requirements and applicable SOPs are being followed properly</li>
<li>Set-up for next shift operations</li>
<li>Encourage and promote good safety practices</li>
<li>Participate and lead Continuous Improvement and Training</li>
</ul>
<p><strong>Desirable qualifications:</strong></p>
<ul>
<li>High school diploma or GED required</li>
<li>Minimum 2 years related experience preferred</li>
<li>Team Oriented</li>
<li>Problem identification and solving</li>
<li>Good communication skills</li>
<li>Good documentation skills, including legible handwriting</li>
<li>Basic computer and math skills</li>
<li>Ability to understand and follow standard operating procedures, specifications, and job-specific training materials</li>
<li>Ability to understand, speak, read and write English</li>
</ul>
<p><strong> </strong><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Must be able to meet 20/20 corrected vision requirement and pass color blind test</li>
<li>Must be able to lift, push/pull, and carry up to 30 pounds</li>
<li>Required to stand for over 4 hours per day, including constant standing for 2 hours at a time</li>
<li>Duties may require overtime work, including weekends</li>
<li>Use of hands and fingers to manipulate equipment is required</li>
</ul>
<p><strong>Additional requirement(s):</strong></p>
<ul>
<li>Final candidates for Finishing Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Employee Ownership Plan</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/25</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4575554007
published: 2025-01-22 20:26:46+00:00
title: Finishing Group Leader (2nd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4575554007
experience_level: SE
language: en
has_remote: False
description:
<p></p>
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p>The Finishing Production Group Leader provides leadership, coaching and communication on an individual and group basis to meet client demand and expectations. The Group Leader contributes to creating an environment where teamwork, productivity, Safety, Identity, Strength, Purity and Quality (SISPQ) are reflected in the finished product. This position reports to a Manufacturing Supervisor.</p>
<p><strong> </strong><strong><span><span>The </span></span>responsibilities:</strong></p>
<ul>
<li>Production Operations Monitoring &amp; Execution</li>
<li>Communicate process/equipment delays to appropriate levels of management as well as subsequent shifts</li>
<li>Work with Sr. Technicians to improve line performance (uptime and efficiency)</li>
<li>Manage TOR (Time out of refrigeration) for refrigerated product</li>
<li>Coordinate material delivery and pick-up with Warehouse and Label Control personnel</li>
<li>Manage electronic inventory transactions at the time of activity completion</li>
<li>Coordinate with Technical Services and Engineering to process Technical and Qualification studies, respectively</li>
<li>Monitor and ensure batch record requirements and applicable SOPs are being followed properly</li>
<li>Set-up for next shift operations</li>
<li>Encourage and promote good safety practices</li>
<li>Participate and lead Continuous Improvement and Training</li>
</ul>
<p><strong>Desirable qualifications:</strong></p>
<ul>
<li>High school diploma or GED required</li>
<li>Minimum 2 years related experience preferred</li>
<li>Team Oriented</li>
<li>Problem identification and solving</li>
<li>Good communication skills</li>
<li>Good documentation skills, including legible handwriting</li>
<li>Basic computer and math skills</li>
<li>Ability to understand and follow standard operating procedures, specifications, and job-specific training materials</li>
<li>Ability to understand, speak, read and write English</li>
</ul>
<p><strong> </strong><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Must be able to meet 20/20 corrected vision requirement and pass color blind test</li>
<li>Must be able to lift, push/pull, and carry up to 30 pounds</li>
<li>Required to stand for over 4 hours per day, including constant standing for 2 hours at a time</li>
<li>Duties may require overtime work, including weekends</li>
<li>Use of hands and fingers to manipulate equipment is required</li>
</ul>
<p><strong>Additional requirement(s):</strong></p>
<ul>
<li>Final candidates for Finishing Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</li>
</ul>
<p> </p>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4615923007
published: 2025-01-22 20:26:46+00:00
title: Finishing Group Leader (3rd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4615923007
experience_level: SE
language: en
has_remote: False
description:
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong> </strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</a></span></p>
<p> </p>
<p> </p>
<p> </p>
<p><strong></strong></p>
<p><strong>This role:</strong></p>
<p>The Finishing Production Group Leader provides leadership, coaching and communication on an individual and group basis to meet client demand and expectations. The Group Leader contributes to creating an environment where teamwork, productivity, Safety, Identity, Strength, Purity and Quality (SISPQ) are reflected in the finished product. This position reports to a Manufacturing Supervisor.</p>
<p><strong> </strong><strong><span><span>The </span></span>responsibilities:</strong></p>
<ul>
<li>Production Operations Monitoring &amp; Execution</li>
<li>Communicate process/equipment delays to appropriate levels of management as well as subsequent shifts</li>
<li>Work with Sr. Technicians to improve line performance (uptime and efficiency)</li>
<li>Manage TOR (Time out of refrigeration) for refrigerated product</li>
<li>Coordinate material delivery and pick-up with Warehouse and Label Control personnel</li>
<li>Manage electronic inventory transactions at the time of activity completion</li>
<li>Coordinate with Technical Services and Engineering to process Technical and Qualification studies, respectively</li>
<li>Monitor and ensure batch record requirements and applicable SOPs are being followed properly</li>
<li>Set-up for next shift operations</li>
<li>Encourage and promote good safety practices</li>
<li>Participate and lead Continuous Improvement and Training</li>
</ul>
<p><strong>Desirable qualifications:</strong></p>
<ul>
<li>High school diploma or GED required</li>
<li>Minimum 2 years related experience preferred</li>
<li>Team Oriented</li>
<li>Problem identification and solving</li>
<li>Good communication skills</li>
<li>Good documentation skills, including legible handwriting</li>
<li>Basic computer and math skills</li>
<li>Ability to understand and follow standard operating procedures, specifications, and job-specific training materials</li>
<li>Ability to understand, speak, read and write English</li>
</ul>
<p><strong> </strong><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Must be able to meet 20/20 corrected vision requirement and pass color blind test</li>
<li>Must be able to lift, push/pull, and carry up to 30 pounds</li>
<li>Required to stand for over 4 hours per day, including constant standing for 2 hours at a time</li>
<li>Duties may require overtime work, including weekends</li>
<li>Use of hands and fingers to manipulate equipment is required</li>
</ul>
<p><strong>Additional requirement(s):</strong></p>
<ul>
<li>Final candidates for Finishing Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</li>
</ul>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Employee Ownership Plan</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/25</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4551978007
published: 2025-01-22 20:26:46+00:00
title: Formulation Operator (3rd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4551978007
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and</em><em> continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p><span>The Formulation Operator (Operator III) position will work in and maintain a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and non-classified work areas.  Activities include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, weighing materials, formulation of product, and conducting in-process testing and filtration.  The Formulation Operator may be required to cross-train as a support Operator for additional areas.  This position reports to a Manufacturing Supervisor.</span><span> </span></p>
<p> </p>
<p><strong><span><span>The responsibilities</span><span>:</span></span></strong><span> </span></p>
<ul>
<li><span>Understand and follow current Good Manufacturing Practices (cGMP).</span><span> </span></li>
<li><span>Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade C/D work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule. </span><span> </span></li>
<li><span>May be required to cross train as a support operator to assist additional manufacturing areas.</span><span> </span></li>
<li><span>Maintain organization at all times within the classified areas to ensure segregation, readiness and to prevent any contamination or rejection of batches.</span><span> </span></li>
<li><span>Compare Lot numbers to ensure correct material is being used for the specified batch</span><span> </span></li>
<li><span>Complete calculations to determine the amount of material to add based on final weight and sometimes potency</span><span> </span></li>
<li><span>Retrieve and test in-process samples </span><span> </span></li>
<li><span>Use scales and balances to weigh and add wide range of raw material</span><span> </span></li>
<li><span>Clean and sample equipment </span><span> </span></li>
<li><span><span>Assist</span><span> in the training and development of other team members</span></span><span> </span></li>
<li><span><span>Required to </span><span>maintain</span><span> attendance </span><span>in accordance with</span><span> the Bloomington Attendance Policy</span></span><span> </span></li>
<li><span><span>Scheduled weekend o</span><span>vertime will be </span><span>required</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>The work environment</span><span>:  </span></span></strong></p>
<p><span><span>Classified</span><span> pharmaceutical environment wearing required gowning</span><span>. Must</span><span> be able to work safely with materials </span><span>required</span><span> to produce pharmaceutical products, including chemicals, compounds, </span><span>glassware</span><span> and sanitization solutions</span><span>.</span><span>  </span><span>Must be able to occasionally (1-33% of the time) work in a confined/clustered </span><span>work space</span><span>.</span></span><span> </span></p>
<p> </p>
<p><strong><span><span>Desirable qualifications</span><span>:</span></span></strong><span><span>  </span></span></p>
<p><span><span>To</span><span> perform this job successfully an individual must be able to perform each essential duty satisfactorily</span><span>.  </span><span>The requirements listed below are representative of the knowledge, skill, and/or ability required</span><span>.  </span><span>Reasonable accommodations may be made to enable individuals to perform the essential functions:</span></span><span> </span></p>
<ul>
<li><span><span>Ability to work independently</span></span><span> </span></li>
<li><span><span>Good communication</span><span> skills</span></span><span> </span></li>
<li><span><span>Good documentation skills, including legible handwriting</span></span><span> </span></li>
<li><span><span>Good interpersonal skills</span></span><span> </span></li>
<li><span><span>Basic</span><span> computer skills</span></span><span> </span></li>
<li><span><span>Basic math skills</span></span><span> </span></li>
<li><span><span>Knowledge of aseptic manufacturing practices</span></span><span> </span></li>
<li><span><span>Knowledge of standard operating procedures, specifications, and job-specific training </span><span>materials</span></span><span> </span></li>
<li><span><span>Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>Physical / safety requirements:</span></span></strong><span> </span></p>
<ul>
<li><span><span>Occasional</span><span> (</span><span>1</span><span>-33%)</span></span>
<ul>
<li><span>Sitting</span><span>, </span><span>climbing stairs</span><span> and</span><span> ladders, balancing, kneeling, operating control</span><span>s</span></li>
</ul>
</li>
<li><span>Frequent </span><span>(34-66%)</span>
<ul>
<li><span>Standing, walking, reaching forward and overhead, sto</span><span>o</span><span>ping, crouching, </span></li>
<li><span>Pushing and pulling up to </span><span>110</span> <span>lbs</span></li>
<li><span>Lifting and carrying up to 70 </span><span>lbs</span></li>
</ul>
</li>
<li><span>Constant</span><span> (67-100</span><span>%</span><span>)</span>
<ul>
<li><span>Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</span></li>
</ul>
</li>
<li><span><span>Final</span><span> candidates for </span><span>Formulation</span><span> Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>Additional requirements:</span></span></strong></p>
<ul>
<li><span><span>Education and experience -</span></span><span><span> </span><span>High</span><span> School diploma or GED </span><span>required</span><span>, 6 months of </span><span>previous</span><span> Pharmaceutical </span><span>or Manufacturing experience preferred.</span></span></li>
<li><span><span>Language skills -</span></span><span><span> must be able to understand, speak, </span><span>read</span><span> and write English </span><span>in order to</span> <span>comply with</span><span> necessary SOP</span><span>’,</span><span> job-specific training materials, GMP’s, and other manuals.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4590196007
published: 2025-01-22 20:26:46+00:00
title: Lagerhelfer (m/w/d) (Teilzeit 18,75 Stunden, befristet auf 1 Jahr)
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4590196007
experience_level: EN
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen.</p>
<p>Für unser Team suchen wir Sie als <strong>Lagerhelfer (m/w/d) (Teilzeit 18,75 Stunden, befristet auf 1 Jahr).</strong></p>
<p>In dieser Position sind Sie für die termingerechte Produktionsversorgung am Standort Halle (Westf.) verantwortlich. Dies beinhaltet im Einzelnen:</p>
<ul>
<li>Vorbereitung der Ware für die Übergabe in den Produktionsbereich</li>
<li>Vorbereitung der benötigten Trayverpackungen für die Produktion</li>
<li>Kommissionierung von Produktionsaufträgen</li>
<li>Bestandsbuchungen und Etikettierung der Waren</li>
<li>Ein- und Auslagerungen von Paletten und Kleinstgebinden</li>
<li>Bestandsmanagement (Mithilfe bei Inventuren, Bestandsüberprüfung)</li>
<li>Einhaltung der Simtra QA – Richtlinien und der EHS – Richtlinien (Umweltschutz und Arbeitssicherheit)</li>
</ul>
<p><strong>Das bringen Sie mit:</strong></p>
<ul>
<li>Erste Erfahrungen im Lagerbereich wünschenswert</li>
<li>Digitale Affinität</li>
<li>Teamfähigkeit, Flexibilität sowie Gewissenhaftigkeit</li>
<li>Bereitschaft zur Schichtarbeit (Früh-und Spätschicht)</li>
<li>Gute Deutschkenntnisse in Wort und Schrift</li>
</ul>
<p><strong>Das bieten wir Ihnen:</strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>18,75 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Selin Sencan <span>(ssencan@simtra.com).</span></p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4535267007
published: 2025-01-22 20:26:46+00:00
title: Leader (m/w/d) Project Engineering
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4535267007
experience_level: SE
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Für unser Team suchen wir Sie als<strong> Leader (m/w/d) Project Engineering.</strong></p>
<p>In dieser Position sind Sie zuständig für die Führung der Projektleiter:innen und die Sicherstellung der Zielerreichung in der Projektabwicklung.</p>
<p>Dabei gehört zu Ihrem Aufgaben- und Verantwortungsbereich:</p>
<ul>
<li>Führung der Mitarbeitenden im Engineering-Team, einschließlich der Weiterentwicklung, Motivation und Teamentwicklung</li>
<li>Sicherstellung der Zielerreichung (Qualitäten, Termine, Kosten) mithilfe von Project Reviews für alle in der Engineering-Abteilung durchgeführten Projekte, mit besonderem Fokus auf die PMI-gerechte Abwicklung in allen Projektphasen. Außerdem die Bereitstellung von Engineering- und Projektabwicklungs-Know-How zur Unterstützung anderer Abteilungen am Standort Halle</li>
<li>Systematische Analyse von Prozessen und Abläufen unter Verwendung von Lean- und Six-Sigma-Werkzeugen zur kontinuierlichen Verbesserung</li>
<li>Sicherstellung der Durchführung von Qualifizierungsmaßnahmen wie FAT, SAT, IQ, OQ und PQ zur Einhaltung des erforderlichen Qualifikationsniveaus in der Abteilung Engineering</li>
<li>Erarbeitung und Implementierung einer Eigen- und Fremdleistungsstrategie für die Projektabwicklung, sowie die Betreuung geeigneter Engineering- und Montage-Dienstleister in Zusammenarbeit mit den Fachabteilungen</li>
<li>Gewährleistung einer ausreichenden Ressourcenausstattung für die Projekte, sowohl hinsichtlich der Leitung als auch der erforderlichen Fachgewerke</li>
<li>Verantwortung für die Erstellung und ordnungsgemäße Übergabe GMP-gerechter Projekt- und Qualifizierungsdokumentation</li>
</ul>
<p><strong> </strong><strong>Sie bringen mit:</strong></p>
<ul>
<li>Ein abgeschlossenes Studium im Bereich Pharma-, Chemie- oder Biotechnologie oder eine vergleichbare Qualifikation</li>
<li>Mehrjährige Erfahrung in der pharmazeutischen Industrie und in der Abwicklung von Projekten im Anlagenbau</li>
<li>Kenntnisse in den Bereichen Gefriertrocknung, Reinstmedien, HVAC / Raum- und Kältetechnik sind von Vorteil</li>
<li>Erfahrung in der Führung von interdisziplinären Teams und Projekte</li>
<li>Lösungsorientierung und Offenheit für neue Ideen</li>
<li>Kenntnisse in GMP-Vorgaben und entsprechenden Qualitätsstandards</li>
<li>Fließende Deutsch- und sehr gute Englischkenntnisse in Wort und Schrift</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Eine attraktive Vergütung und 30 Tage Urlaub</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, dass sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Lisa-Franziska Root (lroot@simtra.com).</p>
<p>#LI-LK</p>
<p><em>Um mehr über den Datenschutzansatz von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzrichtlinie der Simtra Recruitment Platform: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4626841007
published: 2025-01-22 20:26:46+00:00
title: Logistiker (m/w/d) für die Pharmaproduktion
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4626841007
experience_level: MI
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>


Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen.





<p>Für unser Team suchen wir Sie als <strong>Logistiker (m/w/d)</strong> in der Pharmaproduktion für die <strong>Abteilung Verpackung</strong>.</p>
<p>In dieser Position sind Sie verantwortlich für die Durchführung einer GMP-gerechten Bereitstellung und den Transport der Waren in der Abteilung Verpackung. Zudem führen Sie Dokumentations- und Kontrolltätigkeiten aus. Dies beinhaltet im Einzelnen:</p>
<ul>
<li>Transport von vorkommissionierten Packmittel- und Halbfertigwarenpaletten an die Produktionslinien innerhalb der Abteilung Verpackung</li>
<li>Kontrolle der korrekten Vorkommissionierung und Anlieferung zur Gewährleistung einer störungsfreien Produktion</li>
<li>Auslagerung von Fertigware sowie Abwicklung von Rücklieferungen</li>
<li>Durchführung von Inventuren</li>
<li>Kontinuierliche Sicherstellung eines korrekten physischen und systemseitigen Lagerbestandes</li>
<li>Kommunikation mit den Abteilungen Lager, Produktionsbüro, Planung und Controlling</li>
<li>Einhaltung und Weiterentwicklung von 6S Standards</li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Abgeschlossene Ausbildung als (Fach-)Lagerist (m/w/d), Fachkraft (m/w/d) für Lagerlogistik o.ä. wünschenswert</li>
<li>2 Jahre Berufserfahrung im Lagerbereich wünschenswert</li>
<li>Erfahrung im Umgang mit Flurförderzeugen</li>
<li>Teamfähigkeit, Organisationsgeschick sowie Gewissenhaftigkeit</li>
<li>Kenntnisse im Umgang mit Warenwirtschaftssystemen, z.B. MS Dynamics</li>
<li>Gute Deutsch- und Englischkenntnisse in Wort und Schrift</li>
<li>Bereitschaft zur Arbeit in der Frühschicht (Schichtbeginn um 05:30 Uhr)</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Dinara Joneleit <span>(djoneleit@simtra.com).</span></p>
<p><span>#LI-DJ1</span></p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4556812007
published: 2025-01-22 20:26:46+00:00
title: Machine Operator (3rd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4556812007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p><span><span>The Machine Operator works within the Finishing/Packaging Complex. They ensure maximum equipment efficiency to meet client </span><span>demand</span><span> and expectations. They contribute to creating an environment where teamwork, productivity, safety, identity, strength, </span><span>purity</span><span> and quality (SISPQ) are reflected in the finished product. Machine Operators will support Manual Inspection and Packaging operations when necessary. This position reports to the Finishing Supervisor.</span></span><span> </span></p>
<p> </p>
<p><strong><span><span>The responsibilities: </span></span></strong><span> </span></p>
<ul>
<li><span>Equipment Operation</span><span> </span>
<ul>
<li><span>Follow and execute machine operation according to standard operating procedures (SOPs) and batch record instructions</span><span> </span></li>
<li><span>Maximize equipment efficiency during operation, ensuring first pass quality product</span><span> </span></li>
<li><span>Periodically check/examine units from good and or reject areas to ensure proper equipment function</span><span> </span></li>
<li><span>Challenge equipment and or verification systems according to SOPs or batch record instructions</span><span> </span></li>
<li><span>Document all actions performed at the time of performance; assist with verifying various batch record or other equipment steps for teammates</span><span> </span></li>
<li><span>Communicate equipment issues to subsequent shifts, Supervisor and appropriate personnel</span><span> </span></li>
<li><span>Contact and work with internal resources and or vendors to maintain/improve equipment performance</span><span> </span></li>
<li><span>Meet equipment/line efficiency targets by proactively taking action to prevent downtime; work with upstream or downstream team members to help line flow</span><span> </span></li>
<li><span>Use and sample printed materials to the batch record by First In First Out (FIFO) machine outputs or reports before, during, or after processing</span><span> </span></li>
</ul>
</li>
<li><span>Set-up, Tear down, &amp; Changeover </span><span> </span>
<ul>
<li><span>Thoroughly clean and clear machines in established target timelines between production operations</span><span> </span></li>
<li><span>Perform set-up and changeover activities independently for assigned machine; assist set-up and or changeovers on additional equipment when available</span><span> </span></li>
<li><span>Verify all set-up/changeover steps have been completed properly using set-up checklists</span></li>
<li>Monitor setup and changeover process to ensure completion within target set/changeover time</li>
<li>Assist Quality Assurance and or production clearance personnel with clearance of machine</li>
</ul>
</li>
<li>Machine Trouble shooting
<ul>
<li><span>T</span><span>rack machine faults and or downtime system data as problems occur; share information with Technician/Maintenance/Engineering support and help recommend appropriate action to correct the equipment issue</span></li>
<li><span>Clear most faults and re-start equipment following shutdown with minimal direction or supervision according to SOPs or batch record instructions</span><span> </span></li>
<li><span>Assist with completing work orders for equipment related problems</span><span> </span></li>
<li><span>Provide recommendations and implement solutions to equipment/process challenges</span><span> </span></li>
<li><span>Utilize all available information and support groups to resolve problems in a timely manner with documentation and follow up to problems with inadequate/defect material</span></li>
</ul>
</li>
<li>Continuous Improvement, Training, and Safety
<ul>
<li><span>Train peers and Relief Machine Operators for general equipment operation, setup and changeover</span></li>
<li><span>Work with Finishing Training, Supervisors, Machine Operators, etc. to update/improve SOPs</span><span> </span></li>
<li><span>Immediately address any safety or training deficiencies discovered by you or your team mates; notify appropriate levels of management as necessary</span></li>
</ul>
</li>
<li>Equipment Qualification
<ul>
<li><span>Provide support to equipment qualification/validation</span></li>
<li>Develop SOPs for equipment implementation</li>
<li>Work with Tech Services, Engineering, Maintenance and Production to ensure smooth transition to production use direct support to test components and equipment</li>
</ul>
</li>
<li><span>Other</span>
<ul>
<li><span><span>Required to </span><span>maintain</span><span> attendance </span><span>in accordance with</span><span> the Bloomington Attendance Policy</span></span></li>
<li><span><span>Scheduled weekend overtime will be </span><span>required</span></span><span> </span></li>
<li><span><span>Visual acuity </span><span>20/20 </span><span>with or without </span><span>correct</span><span>ive</span><span> vision </span><span>and ability to</span><span> pass color blind test</span></span><span> </span></li>
<li><span><span>Ensure all safety practices are followed and keep area clean and clear of hazards</span></span><span> </span></li>
</ul>
</li>
</ul>
<p> </p>
<p><strong>The work environment:</strong></p>
<p><span><span>Controlled</span><span> pharmaceutical environment including wearing long sleeves, safety toe shoes, </span><span>gloves</span><span> and safety glasses</span><span>.  </span><span>Ability to work in a team environment on a variety of </span><span>automated packaging equipment.</span></span><span> </span></p>
<p> </p>
<p><strong>Desirable qualifications:</strong><span><span>  </span></span></p>
<p><span><span>To</span><span> perform this job successfully an individual must be able to perform each essential duty satisfactorily</span><span>.  </span><span>The requirements listed below are representative of the knowledge, skill, and/or ability required</span><span>.  </span><span>Reasonable accommodations may be made to enable individuals to perform the essential functions:</span></span><span> </span></p>
<ul>
<li><span><span>Ability to work independently</span></span><span> </span></li>
<li><span><span>Good communication</span><span> skills</span></span><span> </span></li>
<li><span><span>Good documentation skills, including legible handwriting</span></span><span> </span></li>
<li><span><span>Good interpersonal skills</span></span><span> </span></li>
<li><span><span>Basic</span> <span>c</span><span>omputer skills</span></span><span> </span></li>
<li><span><span>Basic math skills</span></span><span> </span></li>
<li><span><span>Knowledge of standard operating procedures, specifications, and job-specific training </span><span>materials</span></span><span> </span></li>
<li><span><span>Requires the </span><span>usage of hand tools for set up and operation of automated equipment</span><span>.</span><span> </span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li><span><span>Occasional</span><span> (0-33%)</span></span>
<ul>
<li><span>Walking, climbing stairs and ladders, </span><span>o</span><span>verhead</span><span> reaching and/or lifting</span><span>, balancing, kneeling, crouching, crawling</span></li>
<li><span>Lift</span><span>ing</span><span> up</span><span> to 38 </span><span>lbs</span></li>
<li><span>Carry</span><span>ing</span><span> 30 </span><span>lbs</span></li>
</ul>
</li>
<li><span>Frequent </span><span>(34-66%)</span>
<ul>
<li><span>Sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controls</span></li>
<li><span>Lift</span><span>ing</span><span> and carry</span><span>ing</span><span> up to 32 </span><span>lbs</span></li>
<li><span>Push</span><span>ing</span><span> and pull</span><span>ing</span><span> up to 16 </span><span>lbs</span></li>
</ul>
</li>
<li>Constant<span> (67-100</span><span>%</span><span>)</span>
<ul>
<li>Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</li>
</ul>
</li>
<li><span><span>Final</span><span> candidates for </span><span>Machine</span><span> Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>Additional requirements:</strong></p>
<ul>
<li><span><span>Education and experience</span></span><span><span>: </span><span>High</span><span> School diploma or GED </span><span>required</span><span>, 6 months of </span><span>previous</span><span> Pharmaceutical or Manufacturing experience preferred.</span></span></li>
<li><span><span>Language skills:</span></span><span><span> must be able to understand, speak, </span><span>read</span><span> and write English </span><span>in order to</span> <span>comply with</span><span> necessary SOP</span><span>’,</span><span> job-specific training materials, GMP’s, and other manuals.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>


ext_id: 4562834007
published: 2025-01-22 20:26:46+00:00
title: Manager (m/f/x) Business Development
location: Remote - EU/UK
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4562834007
experience_level: MI
language: en
has_remote: True
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p>At our plants in Halle/Westphalia and Bloomington/Indiana, we produce drugs for the treatment of various cancers and other life-threatening diseases. </p>
<p>In the role as a <strong>Manager (m/f/x) Business Development,</strong> your overall focus is on sales of Clinical and Development Opportunities. You will identify and implement new sales strategies and build strategic relationships with key internal and external stakeholders.</p>
<p>In your new role, you will be empowered to:</p>
<ul>
<li>Prospecting for new leads, implementing cold campaigns to reach target opportunities with potential new customers, and working directly with the Business Development Executive team to create outbound prospecting processes</li>
<li>Planning, directing and controlling sales and business activities for assigned customers in close collaboration with management</li>
<li>Negotiating contracts for contract manufacturing and clinical development, formulation and packaging services</li>
<li>Maintaining and building long-term customer relationships</li>
<li>Presenting business proposals from development to commercial production, including opportunities to strategically bundle our services</li>
<li>Identifying new business opportunities, markets, customer needs and trends</li>
<li>Attending trade fairs, conferences and seminars to increase awareness of our broader capabilities and as a source of lead generation</li>
<li>Exciting project work in close cooperation with Marketing and Research and Development, particularly in the area of market research and sales promotion</li>
<li>Take a procative role as technical, customer-oriented interface between the costumer and Simtra´s Commercial to create an optimal customer experience</li>
</ul>
<p><strong>What you'll bring:</strong></p>
<ul>
<li>Successfully completed studies in the field of chemistry, industrial engineering or a similar degree in natural sciences</li>
<li>At least 5 years of professional experience in business development, sales or a comparable position </li>
<li>Experience in the pharmaceutical industry, biotechnology or healthcare, preferrable in Antibody-Drug Conjugates (ADC) or contract manufacturing verticals</li>
<li>Process Development/Commercial manufacturing experience in the sterile injectable field is an advantage</li>
<li>Strong analytical skills, problem-solving skills and strong communication and negotiation skills</li>
<li>High level of initiative, self-organization and hands-on mentality</li>
<li>Business fluent in English</li>
<li>30%-50% Travel is required</li>
</ul>
<p><strong>Benefits:</strong></p>
<ul>
<li>An attractive salary</li>
<li>A high-performance and pleasant working environment in a team that is looking forward to meeting you!</li>
<li>Support and promotion of individual career development</li>
<li>Work completely remote across Europe</li>
</ul>
<p>We offer interesting opportunities to committed and talented people. Gender, age, skin color, origin, sexual orientation and disabilities do not play a role - on the contrary: we promote diversity and believe that diversity is an enrichment.</p>
<p>We look forward to receiving the documents relating to your professional career directly via our online system.</p>
<p>If you have any questions, please contact Lisa-Franziska Root (lroot@simtra.com)</p>
<p>#LI-LK</p>
<p><em>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4520778007
published: 2025-01-22 20:26:46+00:00
title: Manager (m/w/d) Learning & Development
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4520778007
experience_level: MI
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Für unser Team suchen wir Sie als<strong> Manager (m/w/d) Learning &amp; Development.</strong></p>
<p>In dieser Position sind Sie zuständig für die Entwicklung und kontinuierliche Verbesserung von standortweiten Schulungskonzepten sowie deren Validierung und der Sicherstellung des Transfers in den betrieblichen Ablauf.</p>
<p>Dabei gehört zu Ihrem Aufgaben- und Verantwortungsbereich:</p>
<ul>
<li>Auf- und Ausbau des Bereichs Learning &amp; Development am Standort inkl. der Definition von Prozessen im Zusammenhang mit Schulungsaktivitäten</li>
<li>Entwicklung und kontinuierliche Verbesserung sowie Validierung der Schulungsprozesse, -Standards und -Tools (z. B. Budgetprozess, Trainingsarten, Trainingsmaterial)</li>
<li>Beratung der Führungskräfte rund um Themen der Einarbeitung und Weiterbildung</li>
<li>Konzeption, Etablierung und ständige Weiterentwicklung eines standortweiten Schulungskatalogs inkl. Entwicklung der Trainings u. a. in Zusammenarbeit mit externen Partnern (z. B. Train-the-Trainer, vom Mitarbeitenden zum Vorgesetzten)</li>
<li>Selbstständige Durchführung von standortweiten Trainings und Workshops</li>
<li>Aufbau und fachliche Leitung einer Trainer-Community</li>
<li>Analyse und Reporting von Schulungsbedarfen, -aktivitäten und -erfolgen sowie Durchführung der Transferkontrolle</li>
<li>Führung und Weiterentwicklung des eigenen kleinen Teams</li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Erfolgreich abgeschlossenes Studium im Bereich (Wirtschafts-) Psychologie, Betriebswirtschaftslehre, Pädagogik, Ingenieurswesen oder Ähnliches</li>
<li>5 – 7 Jahre Berufserfahrung in der Personal- und Organisationsentwicklung</li>
<li>Erfahrung im Aufbau des Bereiches L&amp;D von Vorteil</li>
<li>Erfahrung in der Mitarbeiterführung von Vorteil</li>
<li>Zertifizierte Ausbildung zum Trainer / Coach wünschenswert</li>
<li>Fließend Deutsch- und sehr gute Englischkenntnisse in Wort und Schrift</li>
<li>„People mindset“, Beratungskompetenz sowie gute analytische Fähigkeiten</li>
</ul>
<p><strong>Das bieten wir Ihnen:</strong></p>
<ul>
<li>Eine attraktive Vergütung und 30 Tage Urlaub</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Unterstützung und Förderung der individuellen Karriereentwicklung</li>
<li>Job-Rad Leasing</li>
<li>Hauseigene moderne Kantine mit attraktiver Bezuschussung</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Lisa-Franziska Root (lroot@simtra.com).</p>
<p>#LI-LK</p>
<p><em>Um mehr über den Datenschutzansatz von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzrichtlinie der Simtra Recruitment Platform: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4621264007
published: 2025-01-22 20:26:46+00:00
title: Manual Inspection Group Leader
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4621264007
experience_level: SE
language: en
has_remote: False
description:
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong> </strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0"><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</a></span></p>
<p><span><a href="https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&amp;FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&amp;view=0">Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</a></span></p>
<p> </p>
<p> </p>
<p> </p>
<p><strong></strong></p>
<p><strong>This role:</strong></p>
<p>The Manual Inspection Group Leader provides leadership, coaching and communication on an individual and group basis to meet client demand and expectations.  The Group Leader contributes to creating an environment where teamwork, productivity, Safety, Identity, Strength, Purity and Quality are reflected in the finished product.  This position reports to a Finishing Supervisor.</p>
<p><strong> </strong></p>
<p><strong>The responsibilities:</strong></p>
<p>Manual Inspection Operations Monitoring &amp; Execution</p>
<ul>
<li>
<ul>
<li>Monitor Manual Inspection performance and update visual controls</li>
<li>Communicate processt delays to appropriate levels of management as well as subsequent shifts</li>
<li>Manage and track TOR (Time out of refrigeration) for refrigerated product</li>
<li>Coordinate material delivery and pick-up with Warehouse and Label Control personnel</li>
<li>Manage electronic inventory transactions at the time of activity completion</li>
<li>Coordinate with Technical Services and Engineering to process Technical and Qualification studies, respectively</li>
<li>Monitor and ensure batch record requirements and applicable SOPs (Standard Operating Procedures) are being followed/executed properly</li>
<li>Input data into electronic reports</li>
</ul>
</li>
</ul>
<p>Batch Record Review and Completion</p>
<ul>
<li>Discover and correct any documentation errors that occur</li>
<li>Ensure no documentation omissions exist and all activities are documented at the time of performance</li>
<li>Complete batch record review immediately following batch completion</li>
<li>Ensure batch record reviews allow achievement of desired first pass quality</li>
<li>Review batch record and batch record forms for accuracy and completeness; sign for review</li>
<li>Successfully complete batch record review course and qualification</li>
<li>Meet with subsequent shift group leader to review critical batch record information and documentation</li>
<li>Assist with investigations stemming from production deviations or errors</li>
</ul>
<p>Talent Development and Coaching</p>
<ul>
<li>Develop operators in their respective competencies via coaching and creating opportunities to learn/perform new responsibilities</li>
<li>Provide verbal and written feedback for individuals with whom you have led or worked with for performance evaluations and individual development</li>
<li>Communicate client demand, processing instructions and objective to team members</li>
</ul>
<p>Set-up/Tear down/Clearance</p>
<ul>
<li>Organize and assign responsibilities for area clearances</li>
<li>Review and confirm comprehension of FSS (Finishing Specification Sheet) for Manual Inspection operators</li>
<li>Ensure clearance activities meet established turnaround targets</li>
<li>Allocate appropriate personnel to complete assigned tasks</li>
</ul>
<p>Other</p>
<ul>
<li>Required to maintain attendance in accordance with the Bloomington Attendance Policy</li>
<li>Scheduled weekend overtime may be required</li>
<li>Visual acuity 20/20 with or without corrective vision and ability to pass color blind test</li>
<li>Ability to successfully pass all Manual Inspection qualifications</li>
<li>Ensure all safety practices are followed and keep area clean and clear of hazards</li>
</ul>
<p><strong>The work environment:</strong></p>
<p>Controlled pharmaceutical environment including wearing long sleeves, safety toe shoes, gloves and safety glasses.  Ability to work in a team environment on a variety of automated and semi-automated packaging lines.</p>
<p><strong> </strong></p>
<p><strong>Desir</strong>a<strong>ble qualifications:</strong></p>
<ul>
<li>High school diploma or GED required</li>
<li>Minimum 2 years related experience preferred</li>
<li>Team Oriented</li>
<li>Problem identification and solving</li>
<li>Good communication skills</li>
<li>Good documentation skills, including legible handwriting</li>
<li>Basic computer and math skills</li>
<li>Ability to understand and follow standard operating procedures, specifications, and job-specific training materials</li>
<li>Ability to understand, speak, read and write English</li>
</ul>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Must be able to meet 20/20 corrected vision requirement and pass color blind test</li>
<li>Must be able to lift, push/pull, and carry up to 35 pounds</li>
<li>Duties may require overtime work, including weekends</li>
<li>Use of hands and fingers to manipulate equipment is required</li>
</ul>
<p> </p>
<p><strong>Additional requirement(s):</strong></p>
<p>Final candidates for Manual Inspection Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</p>
<p><strong></strong></p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
<li>Employee Ownership Plan</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/25</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4599238007
published: 2025-01-22 20:26:46+00:00
title: Manufacturing Supervisor, Filling/Capping (2nd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4599238007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>The role:</strong></p>
<p>The Supervisor, Manufacturing is a member of the Manufacturing Leadership Team and reports directly to the Manufacturing Manager. They provide direct support to Manufacturing personnel and engaged in production of injectable drug products. The Supervisor, Manufacturing provides decision making and oversight to ensure compliance to all standard operating procedures and batch records.  They must communicate effectively with manufacturing support departments (Quality, Technical Services, Engineering, etc.), multiple levels of management, and other customer support departments. The Supervisor, Manufacturing builds an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.</p>
<p>Schedule: Monday-Friday, 3:00pm-11:30pm + weekend coverage rotation</p>
<p><strong>Its responsibilities:</strong></p>
<ul>
<li>Understand and follow current Good Manufacturing Practices</li>
<li>Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.</li>
<li>Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.</li>
<li>Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities – to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.</li>
<li>Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.</li>
<li>Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.</li>
<li>Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.</li>
<li>Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.</li>
<li>Resolve technical, material and cGMP problems that may impact project deadlines.</li>
<li>Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.</li>
<li>Obtain qualification to perform select critical operation processes.</li>
<li>Represent the company during audits and inspections.</li>
</ul>
<p><strong>Desirable qualifications:</strong></p>
<ul>
<li>High School diploma or GED required</li>
<li>Bachelor's Degree strongly preferred</li>
<li>Minimum 2 years of manufacturing experience required</li>
<li>Minimum 1 year leadership experience required</li>
<li>Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Maximo, Trackwise, Microsoft Dynamics, etc.)</li>
</ul>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Ability to stand or sit for extended periods of time</li>
<li>Ability to lift up to 50 pounds</li>
<li>Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)</li>
<li>Must be able to perform overhead work (ie: sanitizing walls and ceilings)</li>
<li>Physical coordination/flexibility to allow gowning for clean room environments</li>
<li>Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection</li>
<li>Dexterity and physical condition to perform some level of repetitive motion tasks</li>
<li>Ability to wear respirator usage when product or task requires</li>
<li>Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)</li>
<li>Use of hands and fingers to manipulate office equipment is required</li>
<li>Must be able to gown qualify for Grade A/B areas (filling)</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4609575007
published: 2025-01-22 20:26:46+00:00
title: Manufacturing Supervisor, Formulation/Preparation (3rd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4609575007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p><strong>The role:</strong></p>
<p>The Supervisor, Manufacturing is a member of the Manufacturing Leadership Team and reports directly to the Manufacturing Manager. They provide direct support to Manufacturing personnel and engaged in production of injectable drug products. The Supervisor, Manufacturing provides decision making and oversight to ensure compliance to all standard operating procedures and batch records.  They must communicate effectively with manufacturing support departments (Quality, Technical Services, Engineering, etc.), multiple levels of management, and other customer support departments. The Supervisor, Manufacturing builds an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.</p>
<p>Schedule: Sunday night 11pm- Friday morning 7:30am + weekend coverage rotation</p>
<p><strong>Its responsibilities:</strong></p>
<ul>
<li>Understand and follow current Good Manufacturing Practices</li>
<li>Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.</li>
<li>Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.</li>
<li>Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities – to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.</li>
<li>Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.</li>
<li>Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.</li>
<li>Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.</li>
<li>Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.</li>
<li>Resolve technical, material and cGMP problems that may impact project deadlines.</li>
<li>Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.</li>
<li>Obtain qualification to perform select critical operation processes.</li>
<li>Represent the company during audits and inspections.</li>
</ul>
<p><strong>Desirable qualifications:</strong></p>
<ul>
<li>High School diploma or GED required</li>
<li>Bachelor's Degree strongly preferred</li>
<li>Minimum 2 years of manufacturing experience required</li>
<li>Minimum 1 year leadership experience required</li>
<li>Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Maximo, Trackwise, Microsoft Dynamics, etc.)</li>
</ul>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Ability to stand or sit for extended periods of time</li>
<li>Ability to lift up to 50 pounds</li>
<li>Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)</li>
<li>Must be able to perform overhead work (ie: sanitizing walls and ceilings)</li>
<li>Physical coordination/flexibility to allow gowning for clean room environments</li>
<li>Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection</li>
<li>Dexterity and physical condition to perform some level of repetitive motion tasks</li>
<li>Ability to wear respirator usage when product or task requires</li>
<li>Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)</li>
<li>Use of hands and fingers to manipulate office equipment is required</li>
<li>Must be able to gown qualify for Grade A/B areas (filling)</li>
</ul>
<p><strong>In return, you’ll be eligible for</strong><strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4582055007
published: 2025-01-22 20:26:46+00:00
title: Manufacturing Technical Services Representative
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4582055007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p><strong>This role:</strong></p>
<p>The Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.</p>
<p> </p>
<p><strong><span><span>The </span></span>responsibilities:</strong></p>
<ul>
<li>Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs</li>
<li>Review and release commercial batch records to production for execution</li>
<li>Train manufacturing personnel on new and/or significant changes to MBRs</li>
<li>Investigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s)</li>
<li>Authors technical studies in support of investigations or process improvements</li>
<li>Own change controls and associated tasks</li>
<li>Approve project related Bill of Materials</li>
<li>Commercial contact for assigned internal and external clients</li>
<li>Manages client project updates and reviews with all levels of management</li>
<li>Participate (with assistance) in Business Review Meetings</li>
<li>Partner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information</li>
<li>Participate on client calls and on-site visits to discuss projects and issue resolutions</li>
<li>Participate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations</li>
<li>Evaluates non-conformance situations for product impact and responsible for advising if product meets release criteria</li>
<li>Use knowledge of manufacturing systems and equipment to write batch record and perform other duties</li>
<li>Understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product</li>
</ul>
<p><strong> </strong></p>
<p><strong>Required qualifications:</strong></p>
<ul>
<li>BS degree, preferably in a science-related field</li>
<li>Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality</li>
<li>Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization</li>
<li>Strong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently</li>
<li>Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)</li>
<li>Ability to use enterprise software (i.e., JDE, Trackwise, etc.)</li>
<li>Ability to qualify for Grade C areas</li>
</ul>
<p><strong> </strong></p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Duties may require overtime work, including nights and weekends</li>
<li>Position may require sitting or standing for long periods of time</li>
<li>Ability to qualify for Grade C areas</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for </strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4513980007
published: 2025-01-22 20:26:46+00:00
title: Manufacturing Technical Writer
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4513980007
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p>The Manufacturing Technical Writer is responsible for performing site Non-Conformance Report (NCR) and Significant SNCRs investigations, utilizing investigative tools, identifying the root cause(s), documenting the results and processing the relevant records in the corporate Trackwise system, collaborating with impacted departments to determine appropriate corrective or preventive actions and related effectiveness criteria. Personnel filling this role will be the primary investigator for the NCR and SNCRs for the entire Bloomington facility. This candidate will sit onsite at the Bloomington facility and report to the Sr. Manager, Technical Services.</p>
<p><strong> </strong></p>
<p><strong><span><span>The </span></span>responsibilities:</strong></p>
<ul>
<li>Develop the scope and devise an approach for assigned investigations</li>
<li>Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools</li>
<li>Identify cross-functional team members and assemble the investigation team</li>
<li>Confirm corrections/containment identified based on the investigation results</li>
<li>Determine the appropriate data sources to be evaluated for the investigation and obtain the required data</li>
<li>Investigate the root cause(s) of the issue and document the investigation results</li>
<li>Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle</li>
<li>Collaborate with Action Owner/CAPA (Corrective Action and Preventive Action) Owner to develop the Action Plan/Effectiveness Plan</li>
<li>Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs)</li>
<li>Manage multiple investigations at any given time</li>
<li>Responsible for speaking to client auditors and regulatory authorities to explain investigations</li>
</ul>
<p> </p>
<p><strong>Required qualifications:</strong></p>
<ul>
<li>BS degree required, preferably in a science or technical area or equivalent experience</li>
<li>2+ years technical writing experience, preferably in pharmaceutical industry</li>
<li>Knowledge of applicable CAPA procedures, specifications, regulations and standards</li>
<li>Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency</li>
<li>Goal-setting, prioritize, organization, attention to detail, and time management skills</li>
<li>Critical &amp; creative thinking and problem-solving skills</li>
<li>Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data</li>
<li>Strong oral and written communication skills</li>
<li>Ability to demonstrate strong leadership skills</li>
<li>Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)</li>
<li>Ability to utilize enterprise software systems (Trackwise)</li>
</ul>
<p> </p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Duties will require overtime work, including nights and weekends on occasion</li>
<li>Ability to gown in C/D gowning area</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for </strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4558462007
published: 2025-01-22 20:26:46+00:00
title: Manufacturing Trainer (2nd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4558462007
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p>The Manufacturing Trainer is a member of the Manufacturing Team reporting directly to the Lead Trainer Manufacturing. They provide direct support to manufacturing personnel to ensure Good Manufacturing Practices (GMP) and core competencies are met.  The Manufacturing Trainer provides oversight to ensure compliance to all regulatory agency regulations and guidelines and to Standard Operating Procedures. The manufacturing trainer must be able to manage time effectively, build efficiency into the training process, and have a desire to improve processes.  The ideal candidate will be vested in their own personal growth and excited to support the growth of others.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Manufacturing Trainer creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. </p>
<p><strong> </strong></p>
<p><strong>The responsibilities:</strong></p>
<ul>
<li>Ability to effectively train employees on manufacturing core curriculum, highly focused on OJT (on the job training)</li>
<li>Support supervisors in all aspects of the department related to training, (creation and deployment of training policies, processes, and documents, etc.)</li>
<li>Facilitate personnel allocation discussions with leadership ensuring appropriately trained personnel are completing tasks and opportunity for training and growth is provided</li>
<li>Assist with creation of training tools/manuals/job aids for operators to enhance performance</li>
<li>Deliver feedback (and re-training as needed) to team members about their performance in a positive manner that fosters teamwork</li>
<li>Seek feedback from team members to continually improve the training process and program</li>
<li>Perform real-time documentation review of in-process manufacturing activities while coaching GDP principles</li>
<li>Participate on continuous improvement teams</li>
<li>Ensure personnel are completing training documentation appropriately</li>
<li>Write, revise and review pertinent documentation as appropriate</li>
<li>Create and maintain competency depth assessments for assigned shift and/or department</li>
<li>Work with other departments as necessary to create training programs that reinforce and educate employees on the importance of having a Quality focus in daily work</li>
<li>Maintain personal qualifications to provide production support as needed</li>
<li>Provide classroom training as needed</li>
</ul>
<p> </p>
<p><strong>Required qualifications:</strong></p>
<ul>
<li>High School Diploma or GED required.</li>
<li>Minimum of 1 year experience required in Pharmaceutical Manufacturing.</li>
<li>1 year of leadership or training experience preferred.</li>
<li>Strong communication and interpersonal skills.</li>
<li>Ability to provide effective group and individual training.</li>
<li>Experience in technical writing preferred.</li>
<li>Willingness to build efficiency into training processes and manage time effectively.</li>
<li>Demonstrated desire to continually learn.</li>
<li>Knowledge of cGMP and GDP practices required.</li>
<li>Proficiency in a variety of mathematical disciplines and ability to work with both the metric and USA standards of measurement required.</li>
<li>Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, BaxU, etc.)</li>
</ul>
<p><strong> </strong></p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Ability to stand for extended periods of time.</li>
<li>Ability to lift up to 50 pounds.</li>
<li>Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.).</li>
<li>Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection.</li>
<li>Dexterity and physical condition to perform some level of repetitive motion tasks.</li>
<li>Ability to wear respirator usage when product or task requires</li>
<li>Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)</li>
<li>Duties may require overtime work, including nights and weekends</li>
<li>Use of hands and fingers to manipulate office equipment is required.</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4581352007
published: 2025-01-22 20:26:46+00:00
title: Manufacturing Trainer (3rd shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4581352007
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong></strong></p>
<p><strong>This role:</strong></p>
<p>The Manufacturing Trainer is a member of the Manufacturing Team reporting directly to the Lead Trainer Manufacturing. They provide direct support to manufacturing personnel to ensure Good Manufacturing Practices (GMP) and core competencies are met.  The Manufacturing Trainer provides oversight to ensure compliance to all regulatory agency regulations and guidelines and to Standard Operating Procedures. The manufacturing trainer must be able to manage time effectively, build efficiency into the training process, and have a desire to improve processes.  The ideal candidate will be vested in their own personal growth and excited to support the growth of others.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Manufacturing Trainer creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. </p>
<p><strong> </strong></p>
<p><strong>The responsibilities:</strong></p>
<ul>
<li>Ability to effectively train employees on manufacturing core curriculum, highly focused on OJT (on the job training)</li>
<li>Support supervisors in all aspects of the department related to training, (creation and deployment of training policies, processes, and documents, etc.)</li>
<li>Facilitate personnel allocation discussions with leadership ensuring appropriately trained personnel are completing tasks and opportunity for training and growth is provided</li>
<li>Assist with creation of training tools/manuals/job aids for operators to enhance performance</li>
<li>Deliver feedback (and re-training as needed) to team members about their performance in a positive manner that fosters teamwork</li>
<li>Seek feedback from team members to continually improve the training process and program</li>
<li>Perform real-time documentation review of in-process manufacturing activities while coaching GDP principles</li>
<li>Participate on continuous improvement teams</li>
<li>Ensure personnel are completing training documentation appropriately</li>
<li>Write, revise and review pertinent documentation as appropriate</li>
<li>Create and maintain competency depth assessments for assigned shift and/or department</li>
<li>Work with other departments as necessary to create training programs that reinforce and educate employees on the importance of having a Quality focus in daily work</li>
<li>Maintain personal qualifications to provide production support as needed</li>
<li>Provide classroom training as needed</li>
</ul>
<p> </p>
<p><strong>Required qualifications:</strong></p>
<ul>
<li>High School Diploma or GED required.</li>
<li>Minimum of 1 year experience required in Pharmaceutical Manufacturing.</li>
<li>1 year of leadership or training experience preferred.</li>
<li>Strong communication and interpersonal skills.</li>
<li>Ability to provide effective group and individual training.</li>
<li>Experience in technical writing preferred.</li>
<li>Willingness to build efficiency into training processes and manage time effectively.</li>
<li>Demonstrated desire to continually learn.</li>
<li>Knowledge of cGMP and GDP practices required.</li>
<li>Proficiency in a variety of mathematical disciplines and ability to work with both the metric and USA standards of measurement required.</li>
<li>Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, BaxU, etc.)</li>
</ul>
<p><strong> </strong></p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Ability to stand for extended periods of time.</li>
<li>Ability to lift up to 50 pounds.</li>
<li>Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.).</li>
<li>Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection.</li>
<li>Dexterity and physical condition to perform some level of repetitive motion tasks.</li>
<li>Ability to wear respirator usage when product or task requires</li>
<li>Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)</li>
<li>Duties may require overtime work, including nights and weekends</li>
<li>Use of hands and fingers to manipulate office equipment is required.</li>
</ul>
<p><strong></strong></p>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4274036007
published: 2025-01-22 20:26:46+00:00
title: Mechaniker (m/w/d) für die Pharmaproduktion
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4274036007
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen.</p>
<p>Für unser Team suchen wir Sie als <strong>Mechaniker (m/w/d) </strong>für die Pharmaproduktion.</p>
<p>In dieser Position sind Sie für die chargenbezogenen Formatwechsel, Einrichttätigkeiten, Wartungs- und <span>Instandhaltungstätigkeiten</span> und Reparaturarbeiten an den Produktionsmaschinen verantwortlich. Ebenso unterstützen Sie bei der aseptischen Herstellung von flüssigen und gefriergetrockneten Produkten. Des Weiteren gehören zu Ihren Aufgaben:</p>
<ul>
<li>Analyse und Behebung von mechanischen Störungen an Maschinen und Anlagen im Produktionsbereich</li>
<li>Durchführung von Inprozesskontrollen</li>
<li>Beteiligung bei der Vorbereitung von Produktequipment</li>
<li>Unterstützung bei Qualifizierungs- und <span>Validierungstätigkeiten</span></li>
<li>Anwendung von Lean-Tools und Standards (6S, Standard Work, Control Charts, Daily Accountability Boards, Visualisierung, One Point Lessons etc.)</li>
<li>Mitarbeit bei der Verbesserung von Prozessen und Standards</li>
<li>Einhaltung von 6S- und Hygiene-Standards</li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Abgeschlossene technische Ausbildung, vorzugsweise als Industriemechaniker (m/w/d), Maschinen- &amp; Anlagenführer (m/w/d), Verfahrensmechaniker (m/w/d) oder Vergleichbares, z.B. Kfz-Mechatroniker (m/w/d)</li>
<li>Teamfähigkeit, Zuverlässigkeit und <span>Verantwortungsbewusstsein</span></li>
<li>Bereitschaft zur Arbeit im 3-Schicht-Betrieb</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Dinara Joneleit (djoneleit@simtra.com).</p>
<p>#LI-DJ1</p>
<p><em>Um mehr über den Datenschutzansatz von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzrichtlinie der Simtra Recruitment Platform: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4268862007
published: 2025-01-22 20:26:46+00:00
title: Mitarbeiter (m/w/d) für die Pharmaproduktion
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4268862007
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>


Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen.





<p>Für unser Team suchen wir Sie als <strong>Mitarbeiter (m/w/d) für die Pharmaproduktion.</strong></p>
<p>In dieser Position bedienen Sie die Produktionsanlagen einer bestimmten Produktionslinie. Sie sind zuständig für die aseptische Abfüllung und die Bedienung sowie Reinigung der Anlagen. Des Weiteren gehören zu den Aufgaben:</p>
<ul>
<li>Mitarbeit bei der Vorbereitung, der Produktion selbst und der entsprechenden Nachbereitung an den Produktionslinien für flüssige und gefriergetrocknete Produkte</li>
<li>Kontrolle und Führung von Chargendokumentation, Reinigungsdokumentation, Inventarorganisation und Logbüchern</li>
<li>Durchführung von Messungen zum Reinraumnachweis</li>
<li>6S- Verantwortlichkeit für zugewiesene Räume (Ordnungszustand)</li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Abgeschlossene Ausbildung im Bereich der pharmazeutischen, chemischen, Kosmetik-, Lebensmittel- oder Getränkeindustrie oder eine durch Berufserfahrung erworbene vergleichbare Qualifikation</li>
<li>Berufserfahrung in der pharmazeutischen, chemischen, Kosmetik-, Lebensmittel- oder Getränkeindustrie wünschenswert</li>
<li>Selbstständige, sorgfältige und verantwortungsbewusste Arbeitsweise bei der Dokumentation und Durchführung von aseptischen Prozessen (GDP und GMP)</li>
<li>Gute Computer und EDV/Software-Kenntnisse von Vorteil</li>
<li>Bereitschaft zur Arbeit im 3-Schicht-Betrieb</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Dinara Joneleit <span>(djoneleit@simtra.com).</span></p>
<p><span>#LI-DJ1</span></p>
<p><em>Um mehr über den Datenschutzansatz von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzrichtlinie der Simtra Recruitment Platform: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4561429007
published: 2025-01-22 20:26:46+00:00
title: Mitarbeiter (m/w/d) für die sterile Abfüllung
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4561429007
experience_level: MI
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p></p>

Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen.





<p>Für unser Team suchen wir Sie als <strong>Mitarbeiter (m/w/d) für die sterile Abfüllung</strong> in der<strong> </strong>Pharmaproduktion.</p>
<p>In dieser Position sind Sie für die aseptische Herstellung von flüssigen und gefriergetrockneten Produkten zuständig. Des Weiteren gehören zu Ihren Aufgaben:</p>
<ul>
<li>Aseptische Vorbereitung und Nachbereitung von Produktequipment</li>
<li>Bedienung von <span>Pharma-Produktionsmaschinen</span></li>
<li>Durchführung von mikrobiologischen und physikalischen Inprozesskontrollen sowie von einfachen Kalibrierungen</li>
<li>Selbstständige Durchführung der pharmazeutischen Dokumentation</li>
<li>Unterstützung bei der Herstellung von Lösungen im Ansatzbereich</li>
<li>Anwendung von Lean-Tools und Standards (6S, Standard Work, Control Charts, Daily Accountability Boards, Visualisierung, One Point Lessons etc.)</li>
<li>Unterstützung bei Qualifizierungs- und <span>Validierungstätigkeiten</span></li>
<li>Einhaltung von 6S- und Hygiene-Standards</li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Abgeschlossene Ausbildung im Bereich der pharmazeutischen, chemischen, Lebensmittel- oder Getränkeindustrie oder eine durch Berufserfahrung erworbene vergleichbare Qualifikation</li>
<li>Berufserfahrung in der chemischen, pharmazeutischen, Lebensmittel- oder Getränkeindustrie wünschenswert</li>
<li>Verständnis für hygienisches Arbeiten sowie für das Arbeiten im regulierten Umfeld</li>
<li>Selbstständige, disziplinierte und <span>verantwortungsbewusste</span> Arbeitsweise</li>
<li>Bereitschaft zur Arbeit im 3-Schicht-Betrieb</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Dinara Joneleit <span>(djoneleit@simtra.com).</span></p>
<p><span>#LI-DJ1</span></p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4541108007
published: 2025-01-22 20:26:46+00:00
title: Mitarbeiter (m/w/d) im Ansatzbereich
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4541108007
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen.</p>
<p>Für unser Team suchen wir Sie als <strong>Mitarbeiter (m/w/d) im Ansatzbereich </strong>für die Pharmaproduktion.</p>
<p>In dieser Position sind Sie für die selbstständige Ansatzherstellung, entsprechend den schriftlichen Vorgaben, zuständig. Des Weiteren gehören zu Ihren Aufgaben:</p>
<ul>
<li>Eigenständige Durchführung der pharmazeutischen Dokumentation</li>
<li>Reinigung der <span>Filtrationsleitungen,</span> Ansatzisolatoren sowie des Ansatzequipments</li>
<li>Durchführung von Inprozesskontrollen entsprechend der <span>Herstellungsanweisungen,</span> inklusive der Kalibrierung der Messgeräte und Erfassung der Daten</li>
<li>Reinigung, Verpackung und Vorbereitung vom produktberührenden Equipment</li>
<li>Bedienung, Betreuung und Überwachung von Dampf und <span>Heißluftsterilisatoren,</span> Erfassung der Störmeldungen und Organisation der Störungsbeseitigung</li>
<li>Dokumentation der <span>Sterilisationsvorgänge</span> und Kontrolle auf Vollständigkeit</li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Abgeschlossene Ausbildung zum Pharmakanten (m/w/d), Chemikanten (m/w/d), Produktionsfachkraft (m/w/d) Chemie oder PTA/CTA/BTA/LTA (m/w/d) oder eine durch Berufserfahrung erworbene vergleichbare Qualifikation</li>
<li>Berufserfahrung in der chemischen, pharmazeutischen oder <span>Lebensmittel-Industrie</span> wünschenswert</li>
<li>Allgemeine GMP- und GDP-Kenntnisse</li>
<li>Selbstständige, disziplinierte und <span>verantwortungsbewusste</span> Arbeitsweise</li>
<li>Bereitschaft zur Arbeit im 3-Schicht-Betrieb</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Dinara Joneleit <span>(djoneleit@simtra.com).</span></p>
<p><span>#LI-DJ1</span></p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4582915007
published: 2025-01-22 20:26:46+00:00
title: Mitarbeiter (m/w/d) Kalibrierung
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4582915007
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Für unser Team suchen wir Sie als <strong>Mitarbeiter (m/w/d) Kalibrierung.</strong></p>
<p>In dieser Position unterstützen Sie die Abteilung Engineering Services und führen Kalibrierungen an Messeinrichtungen für unterschiedliche physikalische Größen durch. Dies beinhaltet im Einzelnen:</p>
<ul>
<li>Bearbeitung von Kalibrieraufträgen in Werkstätten, Maschinenräumen und technischen Bereichen (Klimaanlagen, Technikebenen), Produktions- und Laborbereiche, Kläranlagen, Ex´schutzbereichen, Reinräumen und Sterilbereichen</li>
<li>Betreuung der Referenzgeräte für Kalibrierungen und deren externen Kalibrierungen, inkl. Einholen von Angeboten und Versandvorbereitung</li>
<li>Bestellung der externen Waagenkalibrierung für den Standort</li>
<li>Betreuung von externen Dienstleistern, die Kalibrierungen am Standort durchführen</li>
<li>Umgang mit unterschiedlichen Softwareanwendungen für die Kalibrierdatenbanken: Datensatzpflege, Erstellung von Zertifikaten und Ausdrucken, Systemanpassungen an Kalibriererfordernisse, Bearbeitung der automatischen Ausdrucke wie z.B. Etiketten, Zertifikate</li>
<li>Nutzung der LEAN-Werkzeuge: 6S, Control Chart und Maßnahmenliste</li>
<li>Einhalten der Richtlinien bzw. Vorschriften im Hinblick auf EHS, GMP, Qualität und gesetzliche Anforderungen</li>
</ul>
<p><strong>Sie bringen mit: </strong></p>
<ul>
<li>Abgeschlossene technische Berufsausbildung oder einer vergleichbaren Qualifikation</li>
<li>Berufserfahrung im Bereich der Pharmaproduktion wünschenswert</li>
<li>Hohe Entscheidungsfähigkeit als auch eine hohe Teamfähigkeit</li>
<li>Zuverlässige, selbstständige und strukturierte Arbeitsweise sowie eine hohe Belastbarkeit</li>
<li>Gute EDV-/Software-Kenntnisse (MS-Office, Maximo, Validator 2000, QM6)</li>
<li>Fließende Deutschkenntnisse sowie gute Englischkenntnisse in Wort und Schrift</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Lisa-Franziska Root <span>(lroot@simtra.com).</span></p>
<p>#LI-LK</p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4595754007
published: 2025-01-22 20:26:46+00:00
title: Mitarbeiter (m/w/d) Konjugation und Aufreinigung
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4595754007
experience_level: MI
language: de
has_remote: False
description:
<p><strong></strong></p>
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen.</p>
<p>Für unser Team suchen wir Sie als <strong>Mitarbeiter (m/w/d) Konjugation und Aufreinigung.</strong></p>
<p>In dieser Position sind Sie verantwortlich für die Herstellung klinischer Produkte unter Einhaltung der GMP- und Sicherheitsstandards, insbesondere für die Konjugations- und Reinigungsschritte (C&amp;P), sowie angrenzende Aktivitäten. Des Weiteren gehören zu Ihren Aufgaben:</p>
<ul>
<li>Mitarbeit an allen Prozessschritten vom Aufbau bis hin zur Produktion</li>
<li>Herstellung und Filtrierung von Lösungen, klinischen Materialien, Konjugationsmischungen und Puffern, die in den C&amp;P-Prozess gelangen</li>
<li>Reinigung, Verpackung und Vorbereitung vom produktberührenden Equipment</li>
<li>Kalibrierung der Messgeräte und Erfassung der Daten</li>
<li>Unterstützung bei Qualifizierungs- und Validierungstätigkeiten</li>
<li>Teilnahme an Untersuchungen von Abweichungen und CAPA-Ausarbeitungen</li>
<li>Aktive Teilnahme an Verbesserungsinitiativen</li>
<li>Einhaltung von 6S- und Hygiene-Standards</li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Abgeschlossene Ausbildung zum Chemikanten (m/w/d) oder Pharmakanten (m/w/d), Produktionsfachkraft (m/w/d) Chemie oder PTA/CTA/BTA/LTA (m/w/d) oder eine durch Berufserfahrung erworbene vergleichbare Qualifikation</li>
<li>Mindestens 2 Jahre Berufserfahrung in der chemischen, pharmazeutischen (oder Lebensmittel-)Industrie erforderlich</li>
<li>Allgemeine GMP- und GDP-Kenntnisse, sowie Erfahrungen mit der Konjugation und Aufreinigung (C&amp;P) wünschenswert</li>
<li>Gute EDV-Kenntnisse (MS-Office)</li>
<li>Selbstständige, disziplinierte und verantwortungsbewusste Arbeitsweise</li>
<li>Sehr gute Deutsch- und gute Englischkenntnisse in Wort und Schrift</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Selin Sencan (ssencan@simtra.com).</p>
<p><em>Um mehr über den Datenschutzansatz von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzrichtlinie der Simtra Recruitment Platform: </em><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy"><em>https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></a></p>


ext_id: 4592494007
published: 2025-01-22 20:26:46+00:00
title: Pharmaceutical Manufacturing Manager (2nd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4592494007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p> </p>
<p><strong>The role:</strong></p>
<p>The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.</p>
<p>The work shift is Monday-Friday 3:00p-11:30p. Including weekend on-call rotation.</p>
<p><strong>Its responsibilities:</strong></p>
<ul>
<li>Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.</li>
<li>Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.</li>
<li>Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.</li>
<li>Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.</li>
<li>Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.</li>
<li>Approves SOP’s, validations, and protocols in a timely manner.</li>
<li>Partners with client teams to support client projects and client audits.</li>
<li>Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.</li>
<li>Ensures organization’s budget is met and maintains expenses within the plan.</li>
<li>Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.</li>
<li>Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.</li>
<li>Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.</li>
<li>Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.</li>
</ul>
<p> </p>
<p><strong>Desirable qualifications:</strong></p>
<ul>
<li>Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.</li>
<li>Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.</li>
<li>Must have knowledge of GMPs and worldwide regulatory agency guidelines.</li>
<li>Minimum 3 years in a leadership role, preferably in parenteral manufacturing.</li>
<li>Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)</li>
<li>Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)</li>
</ul>
<p> </p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Ability to stand for extended periods of time</li>
<li>Physical coordination/flexibility to allow gowning for clean room environments</li>
<li>Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection</li>
<li>Dexterity and physical condition to perform some level of repetitive motion tasks</li>
<li>Ability to wear respirator usage when product or task requires</li>
<li>Duties may require overtime work, including nights and weekends</li>
<li>Use of hands and fingers to manipulate office equipment is required</li>
<li>Must be able to gown qualify for Grade A/B areas (filling)</li>
<li>Position may require sitting for long hours</li>
</ul>
<p> </p>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4592491007
published: 2025-01-22 20:26:46+00:00
title: Pharmaceutical Manufacturing Manager (3rd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4592491007
experience_level: MI
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p><strong>The role:</strong></p>
<p>The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.</p>
<p>The work shift is Sunday-Friday 11:00pm-7:30am.Including weekend on-call rotation.</p>
<p> <strong>Its responsibilities:</strong></p>
<ul>
<li>Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.</li>
<li>Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.</li>
<li>Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.</li>
<li>Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.</li>
<li>Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.</li>
<li>Approves SOP’s, validations, and protocols in a timely manner.</li>
<li>Partners with client teams to support client projects and client audits.</li>
<li>Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.</li>
<li>Ensures organization’s budget is met and maintains expenses within the plan.</li>
<li>Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.</li>
<li>Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.</li>
<li>Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.</li>
<li>Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.</li>
</ul>
<p> </p>
<p><strong>Desirable qualifications:</strong></p>
<ul>
<li>Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.</li>
<li>Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.</li>
<li>Must have knowledge of GMPs and worldwide regulatory agency guidelines.</li>
<li>Minimum 3 years in a leadership role, preferably in parenteral manufacturing.</li>
<li>Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)</li>
<li>Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)</li>
</ul>
<p> </p>
<p><strong>Physical / safety requirements:</strong></p>
<ul>
<li>Ability to stand for extended periods of time</li>
<li>Physical coordination/flexibility to allow gowning for clean room environments</li>
<li>Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection</li>
<li>Dexterity and physical condition to perform some level of repetitive motion tasks</li>
<li>Ability to wear respirator usage when product or task requires</li>
<li>Duties may require overtime work, including nights and weekends</li>
<li>Use of hands and fingers to manipulate office equipment is required</li>
<li>Must be able to gown qualify for Grade A/B areas (filling)</li>
<li>Position may require sitting for long hours</li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4542054007
published: 2025-01-22 20:26:46+00:00
title: Pharmakant / Chemikant / PTA / CTA / BTA / LTA (m/w/d) für die Pharmaproduktion
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4542054007
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen.</p>
<p>Für unser Team suchen wir Sie als <strong>Pharmakanten / Chemikanten / PTA / CTA / BTA / LTA (m/w/d) </strong>für unsere Pharmaproduktion.</p>
<p>In dieser Rolle arbeiten Sie bei <span>Herstellungsprozessen</span> von pharmazeutischen Produkten (klinische und kommerzielle Produkte) mit. Dies beinhaltet im Einzelnen:</p>
<ul>
<li>Bedienung von produktspezifischen Maschinen- und Anlagen inklusive Durchführung von Filtertests</li>
<li>Durchführung von mikrobiologischen und physikalischen Inprozesskontrollen, Messungen und Probentransfers</li>
<li>Unterstützung bei der Durchführung von Testläufen; Inbetriebnahme und Qualifizierungen von Anlagen zur Einführung neuer Produkte in die Routinefertigung</li>
<li>Durchführung von einfachen Kalibrierungen</li>
<li>Kontrollieren und Führen von <span>Chargendokumentation,</span> <span>Reinigungsdokumentation,</span> Inventarorganisation und Logbüchern</li>
<li>Bestellung von Produktions- und <span>Verbrauchsmaterialien</span></li>
</ul>
<p><strong>Sie bringen mit:</strong></p>
<ul>
<li>Abgeschlossene technische Ausbildung, vorzugsweise zum Pharmakanten (m/w/d), Chemikanten (m/w/d), oder PTA/CTA/BTA/LTA (m/w/d), oder zum Maschinen- und Anlagenführer (m/w/d)</li>
<li>Berufsanfänger sind ebenfalls willkommen</li>
<li>Selbstständige, disziplinierte und <span>verantwortungsbewusste</span> Arbeitsweise</li>
<li>Bereitschaft zur Arbeit im 3-Schicht-Betrieb</li>
</ul>
<p><strong>Das bieten wir Ihnen: </strong></p>
<ul>
<li>Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein <strong>13. Tarifgehalt, Urlaubsgeld</strong>, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung</li>
<li>Ein leistungsstarkes und angenehmes Arbeitsumfeld in einem Team, das sich auf Sie freut!</li>
<li>Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung</li>
<li><strong>30 Tage Urlaub</strong> plus Sonderurlaub</li>
<li>Wochenarbeitszeit von <strong>37,5 Stunden</strong></li>
<li>Job-Rad Leasing</li>
<li>Kostenlose Betriebssportarten z.B. Yoga, Squash und Fitnesskurse</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wenden Sie sich gerne an Dinara Joneleit <span>(djoneleit@simtra.com).</span></p>
<p><span>#LI-DJ1</span></p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4172789007
published: 2025-01-22 20:26:46+00:00
title: Praktikant (m/w/d) Human Resources
location: Halle, North Rhine-Westphalia, Germany
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4172789007
experience_level: EN
language: de
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- &amp; Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.</em></p>
<p><em>Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werde ein Teil des Teams und unterstütze zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.</em></p>
<p>Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. </p>
<p>Für unser Team suchen wir dich als<strong> Praktikant (m/w/d) im Bereich Human Resources.</strong></p>
<p>Unsere Zukunft ist Deine Zukunft: Wir wenden uns an engagierte Praktikanten (m/w/d), die ihr Know-how für 6 Monate in ein dynamisches <span>Hochtechnologie-Unternehmen</span> einbringen möchten.</p>
<p>In dieser Position lernst Du die gesamten Aufgaben einer lokalen Personalabteilung <span>kennen. Während Deines</span> <span>Einsatzes unterstützt Du </span>uns bei der operativen Personalarbeit. Du wirkst aktiv von der Anhörung des Betriebsrates über das Onboarding neuer Mitarbeitenden bis zum Verfassen von Arbeitszeugnissen mit. Zudem besteht die Möglichkeit an <span>Vorstellungsgesprächen</span> teilzunehmen und eigene kleine Projekte durchzuführen.</p>
<p><strong>Du bringst mit: </strong></p>
<ul>
<li>Studium der BWL, Sozialwissenschaften, (Wirtschafts-)Psychologie oder eines vergleichbaren Studiengangs</li>
<li>Wünschenswert ist eine kaufmännische Ausbildung, aber nicht Bedingung</li>
<li>Sicherer Umgang mit MS-Office</li>
<li>Gute Englischkenntnisse in Wort und Schrift</li>
<li>Strukturierte und serviceorientierte Arbeitsweise</li>
<li>Zuverlässigkeit, Teamfähigkeit und Eigenständigkeit</li>
</ul>
<p><strong>Das bieten wir dir:</strong></p>
<ul>
<li>Flexible Arbeitszeiten im Rahmen einer 37,5-Stunden-Woche sowie eine attraktive Vergütung</li>
<li>Selbstständiges Arbeiten sowie individuelle Betreuung durch eine definierte Ansprechperson</li>
<li>Hauseigene Kantine sowie kostenloses Wasser &amp; Kaffeespezialitäten</li>
<li>Studentenstammtisch zum Netzwerken &amp; Austauschen mit anderen Studierenden</li>
</ul>
<p>Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.</p>
<p>Wir freuen uns über die Zusendung der Unterlagen zu Deinem bisherigen beruflichen Werdegang direkt über unser Online-System.</p>
<p>Bei Rückfragen wende Dich gerne an Selin Sencan <span>(ssencan@simtra.com).</span></p>
<p><em>Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzerklärung der Simtra Recruitment Plattform durch: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</em></p>


ext_id: 4575463007
published: 2025-01-22 20:26:46+00:00
title: Preparation Operator (2nd Shift)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4575463007
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p><span><span>The Prep Operator (Operator II) will work in and </span><span>maintain</span><span> a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and non-classified work areas. Activities shall include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, integrity testing of filters, and cleaning, setup, and sterilization of equipment and components. Ability to </span><span>operate</span><span> preparation equipment such as autoclaves, </span><span>sonicators</span><span>, </span><span>depyrogenation</span><span> ovens, and vial and stopper washers. The Preparation Operator may </span><span>be required</span><span> to cross-train as a support Operator for </span><span>additional</span><span> areas. This position reports to the Manufacturing Supervisor.</span></span><span> </span></p>
<p> </p>
<p><strong><span><span>The responsibilities</span><span>:</span></span></strong><span> </span></p>
<ul>
<li><span><span>Understand and follow current Good Manufacturing Practices</span></span><span> </span></li>
<li><span><span>Perform routine cleanup and sanitizations as assigned by area supervision to </span><span>maintain</span><span> cGMP compliance within the Grade C/D work areas</span></span><span> </span></li>
<li><span><span>Perform sanitizations in </span><span>a timely</span><span> and effective manner </span><span>in accordance with</span> <span>cGMPs</span><span> and </span><span>Simtra</span><span> procedures, </span><span>maintaining</span><span> production schedule</span></span><span> </span></li>
<li><span><span>Maintain organization at all times</span><span> within the classified areas to ensure segregation, readiness and to prevent any contamination or rejection of batches</span></span><span> </span></li>
<li><span><span>Compare Lot numbers to ensure correct components are being used for the specified batch</span></span><span> </span></li>
<li><span><span>Complete calculations to support preparation activities</span></span><span> </span></li>
<li><span><span>Retrieve and test in-process samples</span></span><span> </span></li>
<li><span><span>Clean and sample equipment</span></span><span> </span></li>
<li><span><span>Required to </span><span>maintain</span><span> attendance </span><span>in accordance with</span><span> the Bloomington Attendance Policy</span></span><span> </span></li>
<li><span><span>Scheduled weekend overtime will be </span><span>required</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>The work environment</span><span>:  </span></span></strong></p>
<p><span><span>Classified</span><span> pharmaceutical environment including wearing required gowning as shown in </span><span>attached document</span><span>.  </span><span>Occasional work with water and pharmaceutical </span><span>product</span><span> while wearing applicable Personal Protective Equipment</span><span>.  </span><span>Must be able to work safely with materials </span><span>required</span><span> to produce pharmaceutical products, including chemicals, compounds, </span><span>glassware</span><span> and sanitization solutions.</span></span><span> </span></p>
<p> </p>
<p><strong>Desirable qualifications:</strong></p>
<p><span><span>To</span><span> perform this job successfully an individual must be able to perform each essential duty satisfactorily</span><span>.  </span><span>The requirements listed below are representative of the knowledge, skill, and/or ability required</span><span>.  </span><span>Reasonable accommodations may be made to enable individuals to perform the essential functions:</span></span><span> </span></p>
<ul>
<li><span><span>Ability to work independently</span></span><span> </span></li>
<li><span><span>Good communication</span><span> skills</span></span><span> </span></li>
<li><span><span>Good documentation skills, including legible handwriting</span></span><span> </span></li>
<li><span><span>Good interpersonal skills</span></span><span> </span></li>
<li><span><span>Basic</span><span> computer skills</span><span>, including ability to navigate enterprise software (</span><span>ie</span><span> Pilgrim, JDE, </span><span>etc</span><span>)</span></span><span> </span></li>
<li><span><span>Basic math skills</span></span><span> </span></li>
<li><span><span>Knowledge of aseptic manufacturing practices</span></span><span> </span></li>
<li><span><span>Knowledge of standard operating procedures, specifications, and job-specific training materials</span></span><span> </span></li>
<li><span><span>Requires the operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as </span><span>calipers, scales, gauges, and other measuring devices</span><span>.  </span><span>Ability to </span><span>demonstrate</span> <span>proficiency</span><span> in reading equipment drawings</span><span>.  </span><span>Ability to work safely with equipment under pressure.</span></span><span> </span></li>
</ul>
<p><span> </span></p>
<p><strong><span><span>Physical / safety requirements:</span></span></strong></p>
<ul>
<li><span><span>Occasional</span><span> (0-33%)</span></span>
<ul>
<li><span>Sitting, climbing stairs and ladders, </span><span>overhead </span><span>reaching </span><span>and/or lifting</span><span>, balancing, kneeling, crouching, crawling, operating controls</span></li>
<li><span>Lift</span><span>ing</span><span> and carry</span><span>ing</span><span> up to 53 </span><span>lbs</span></li>
<li>Push<span>ing</span><span> up to 105 </span><span>lbs</span></li>
<li>Pull<span>ing </span><span>up to </span><span>105</span> <span>lbs</span></li>
</ul>
</li>
<li>Frequent <span>(34-66%)</span>
<ul>
<li>Standing, walking, reaching forward, stooping, object handling, fingering, fine hand coordination simple and firm hand grasping </li>
<li>Lift<span>ing</span><span> and carry</span><span>ing</span><span> up to </span><span>44</span> <span>lbs</span></li>
<li>Push<span>ing</span><span> and pull</span><span>ing</span><span> up to 15 </span><span>lbs</span><span> </span></li>
</ul>
</li>
<li>Constant<span> (67-100</span><span>%</span><span>)</span>
<ul>
<li>Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</li>
</ul>
</li>
<li><span><span>Final candidates for </span><span>Prep</span><span> Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>Additional requirement(s):</strong></p>
<p> </p>
<ul>
<li><span><span>Education and experience</span></span><span><span>: </span><span>High</span><span> School diploma or GED </span><span>required</span><span>, 6 months of </span><span>previous</span><span> Pharmaceutical or Manufacturing experience preferred.</span></span></li>
<li><span><span>Language Skills:</span></span><span><span>  Must be able to understand, speak, </span><span>read</span><span> and write English </span><span>in order to</span> <span>comply with</span><span> necessary SOP</span><span>’,</span><span> job-specific training materials, GMP’s, and other manuals.</span></span></li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


ext_id: 4548800007
published: 2025-01-22 20:26:46+00:00
title: Preparation Operator (3rd Shift Weekends)
location: Bloomington, Indiana, United States
application_url: https://job-boards.greenhouse.io/simtrabps/jobs/4548800007
language: en
has_remote: False
description:
<p><em>Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  </em></p>
<p><em>Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.</em></p>
<p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>  <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p>
<p><strong> </strong></p>
<p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p>
<p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p>
<p>Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.</p>
<p>Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p>
<p>Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.</p>
<p> </p>
<p> </p>
<p><strong>This role:</strong></p>
<p><span><span>The Prep Operator (Operator II) will work in and </span><span>maintain</span><span> a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and non-classified work areas. Activities shall include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, integrity testing of filters, and cleaning, setup, and sterilization of equipment and components. Ability to </span><span>operate</span><span> preparation equipment such as autoclaves, </span><span>sonicators</span><span>, </span><span>depyrogenation</span><span> ovens, and vial and stopper washers. The Preparation Operator may </span><span>be required</span><span> to cross-train as a support Operator for </span><span>additional</span><span> areas. This position reports to the Manufacturing Supervisor.</span></span><span> </span></p>
<p><span></span></p>
<p>This position is required to work all designated plant holidays.</p>
<p>3rd shift, Weekends:  Saturday/Sunday 11pm – 9:30am, plus 2 weekdays (either Mon/Tues or Thurs/Fri) 11pm – 7:30am. </p>
<p><strong><span><span>The responsibilities</span><span>:</span></span></strong><span> </span></p>
<ul>
<li><span><span>Understand and follow current Good Manufacturing Practices</span></span><span> </span></li>
<li><span><span>Perform routine cleanup and sanitizations as assigned by area supervision to </span><span>maintain</span><span> cGMP compliance within the Grade C/D work areas</span></span><span> </span></li>
<li><span><span>Perform sanitizations in </span><span>a timely</span><span> and effective manner </span><span>in accordance with</span> <span>cGMPs</span><span> and </span><span>Simtra</span><span> procedures, </span><span>maintaining</span><span> production schedule</span></span><span> </span></li>
<li><span><span>Maintain organization at all times</span><span> within the classified areas to ensure segregation, readiness and to prevent any contamination or rejection of batches</span></span><span> </span></li>
<li><span><span>Compare Lot numbers to ensure correct components are being used for the specified batch</span></span><span> </span></li>
<li><span><span>Complete calculations to support preparation activities</span></span><span> </span></li>
<li><span><span>Retrieve and test in-process samples</span></span><span> </span></li>
<li><span><span>Clean and sample equipment</span></span><span> </span></li>
<li><span><span>Required to </span><span>maintain</span><span> attendance </span><span>in accordance with</span><span> the Bloomington Attendance Policy</span></span><span> </span></li>
<li><span><span>Scheduled weekend overtime will be </span><span>required</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong><span><span>The work environment</span><span>:  </span></span></strong></p>
<p><span><span>Classified</span><span> pharmaceutical environment including wearing required gowning as shown in </span><span>attached document</span><span>.  </span><span>Occasional work with water and pharmaceutical </span><span>product</span><span> while wearing applicable Personal Protective Equipment</span><span>.  </span><span>Must be able to work safely with materials </span><span>required</span><span> to produce pharmaceutical products, including chemicals, compounds, </span><span>glassware</span><span> and sanitization solutions.</span></span><span> </span></p>
<p> </p>
<p><strong>Desirable qualifications:</strong></p>
<p><span><span>To</span><span> perform this job successfully an individual must be able to perform each essential duty satisfactorily</span><span>.  </span><span>The requirements listed below are representative of the knowledge, skill, and/or ability required</span><span>.  </span><span>Reasonable accommodations may be made to enable individuals to perform the essential functions:</span></span><span> </span></p>
<ul>
<li><span><span>Ability to work independently</span></span><span> </span></li>
<li><span><span>Good communication</span><span> skills</span></span><span> </span></li>
<li><span><span>Good documentation skills, including legible handwriting</span></span><span> </span></li>
<li><span><span>Good interpersonal skills</span></span><span> </span></li>
<li><span><span>Basic</span><span> computer skills</span><span>, including ability to navigate enterprise software (</span><span>ie</span><span> Pilgrim, JDE, </span><span>etc</span><span>)</span></span><span> </span></li>
<li><span><span>Basic math skills</span></span><span> </span></li>
<li><span><span>Knowledge of aseptic manufacturing practices</span></span><span> </span></li>
<li><span><span>Knowledge of standard operating procedures, specifications, and job-specific training materials</span></span><span> </span></li>
<li><span><span>Requires the operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as </span><span>calipers, scales, gauges, and other measuring devices</span><span>.  </span><span>Ability to </span><span>demonstrate</span> <span>proficiency</span><span> in reading equipment drawings</span><span>.  </span><span>Ability to work safely with equipment under pressure.</span></span><span> </span></li>
</ul>
<p><span> </span></p>
<p><strong><span><span>Physical / safety requirements:</span></span></strong></p>
<ul>
<li><span><span>Occasional</span><span> (0-33%)</span></span>
<ul>
<li><span>Sitting, climbing stairs and ladders, </span><span>overhead </span><span>reaching </span><span>and/or lifting</span><span>, balancing, kneeling, crouching, crawling, operating controls</span></li>
<li><span>Lift</span><span>ing</span><span> and carry</span><span>ing</span><span> up to 53 </span><span>lbs</span></li>
<li>Push<span>ing</span><span> up to 105 </span><span>lbs</span></li>
<li>Pull<span>ing </span><span>up to </span><span>105</span> <span>lbs</span></li>
</ul>
</li>
<li>Frequent <span>(34-66%)</span>
<ul>
<li>Standing, walking, reaching forward, stooping, object handling, fingering, fine hand coordination simple and firm hand grasping </li>
<li>Lift<span>ing</span><span> and carry</span><span>ing</span><span> up to </span><span>44</span> <span>lbs</span></li>
<li>Push<span>ing</span><span> and pull</span><span>ing</span><span> up to 15 </span><span>lbs</span><span> </span></li>
</ul>
</li>
<li>Constant<span> (67-100</span><span>%</span><span>)</span>
<ul>
<li>Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping</li>
</ul>
</li>
<li><span><span>Final candidates for </span><span>Prep</span><span> Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.</span></span><span> </span></li>
</ul>
<p> </p>
<p><strong>Additional requirement(s):</strong></p>
<p> </p>
<ul>
<li><span><span>Education and experience</span></span><span><span>: </span><span>High</span><span> School diploma or GED </span><span>required</span><span>, 6 months of </span><span>previous</span><span> Pharmaceutical or Manufacturing experience preferred.</span></span></li>
<li><span><span>Language Skills:</span></span><span><span>  Must be able to understand, speak, </span><span>read</span><span> and write English </span><span>in order to</span> <span>comply with</span><span> necessary SOP</span><span>’,</span><span> job-specific training materials, GMP’s, and other manuals.</span></span></li>
</ul>
<p> </p>
<p><strong>In return, you’ll be eligible for</strong>[1]<strong>:</strong></p>
<ul>
<li><strong> </strong>Day One Benefits
<ul>
<li>Medical &amp; Dental Coverage</li>
<li>Flexible Spending Accounts</li>
<li>Life and AD&amp;D Insurance</li>
<li>Supplemental Life Insurance
<ul>
<li>Spouse Life Insurance</li>
<li>Child Life Insurance</li>
</ul>
</li>
<li>Short and Long-Term Disability Insurance</li>
<li>401(k) Retirement Savings Plan with Company Match</li>
<li>Time Off Program
<ul>
<li>Paid Holidays</li>
<li>Paid Time Off</li>
<li>Paid Parental Leave and more</li>
</ul>
</li>
<li>Adoption Reimbursement Program</li>
<li>Education Assistance Program</li>
<li>Employee Assistance Program</li>
<li>Community and Volunteer Service Program</li>
</ul>
</li>
<li>Additional Benefits
<ul>
<li>Voluntary Insurance Benefits
<ul>
<li>Vision Coverage</li>
<li>Accident</li>
<li>Critical Illness</li>
<li>Hospital Indemnity Insurance</li>
<li>Identity Theft Protection</li>
<li>Legal and more</li>
</ul>
</li>
<li>Onsite Campus Amenities
<ul>
<li>Workout Facility</li>
<li>Cafeteria</li>
<li>Credit Union</li>
</ul>
</li>
</ul>
</li>
</ul>
<p>[1] Current benefit offerings are in effect through 12/31/24</p>
<p> </p>
<p> </p>
<p><strong>Disclaimer</strong></p>
<p>This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.</p>
<p><strong> </strong></p>
<p><strong>Equal Employment Opportunity</strong></p>
<p>Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.<br/>                                                                                                                                                             <br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf">EEO is the Law </a><br/><a href="http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf">EEO is the law - Poster Supplement</a> <br/><a href="https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf">Pay Transparency Policy</a></p>
<p> </p>
<p><strong>Data Privacy</strong></p>
<p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:</p>
<p><a href="https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy">https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy</a></p>
<p> </p>


