Simtra BioPharma Solutions
Validation Lead/Associate III, Commissioning Qualification, Validation
Bloomington, Indiana, United States · Mid
Sponsorship not specifiedDetected 12 days ago
AirflowExcelGMPLeadershipProblem SolvingCritical ThinkingMicrosoft Office
About the role
- 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.
- 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.
Responsibilities
- Provide guidance, support, direction, and leadership through positive interaction with all personnel during daily operations.
- Develops procedures and supports the facility equipment qualification and validation program.
- Initiates and drives change controls (CCM).
- Author and approve qualification and validation documents
- Leads and participates in planned maintenance activities, including HEPA certification and visual airflow testing (smoke testing).
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- Bachelor's degree required, preferably in a science or technical area
- Minimum of 2 years related experience required, preferably 2 years supervisory experience.
- Computer proficiency in Microsoft Word,
- Ability to meet Grade C and D gowning requirements.
- Use of hands and fingers to manipulate equipment is required.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Benefits
- 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.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
Equal opportunity
- 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.
- Data Privacy
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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.