Simtra BioPharma Solutions
Sterility Assurance Validation Associate I (1st shift)
Bloomington, Indiana, United States · Senior
Sponsorship not specifiedDetected 12 days ago
ExcelGMPCommunicationProblem SolvingCritical ThinkingWritingMicrosoft 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
- Document (protocols, SOPs, summary reports) new processes and update existing processes where vital that will be reviewed by clients, corporate and regulatory auditors
- Owns and onboards new client projects, including the relevant validations on syringe lines
- Collaborates directly with client representatives
- Owns non-conformance investigations (NCR)
- Owns corrective and preventive actions (CAPA)
- Owns change control management tasks (CCM)
- Participates in client audits and provides rationale / justification for practices with aid from senior team member / management Responds to audit observations and owns deliverables
- Owns, plans interventions and leads syringe line media fills and has full ownership through closure of the summary
- Owns & drives value improvement projects (VIP) to realize savings
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- Microsoft Office Suite (Word, Excel, Outlook) intermediate proficiency
- Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.)
- High initiative and ability to deal with ambiguity
- Ability to meet Grade A and B gowning requirements.
- Ability to lift 50 lbs.
- Must be able to climb and work from ladders.
Compensation
- Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing)
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
Company info
- The Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes.
- The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements, internal company standards/best practices and current industry practices.
- This position is 100% onsite at the Bloomington facility and reports to the Sr.
- Technical Services Validation Manager.
- 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.
- While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
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.
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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.