Simtra BioPharma Solutions
Science and Compliance Specialist
Bloomington, Indiana, United States · Mid
Sponsorship not specifiedDetected 12 days ago
ExcelProcess ImprovementGMPFDA RegulatoryLeadershipCommunicationProblem SolvingTime ManagementWritingMicrosoft 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
- Lead and execute investigations for deviations, including defining scope, applying structured problem‑solving methods, and documenting results in compliance with cGMP standards.
- Investigate the root cause(s) of the issue and document the investigation results
- Collaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness
- Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines
- Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall process performance
- Draft, revise, and approve Standard Operating Procedures (SOPs) and other controlled documents to ensure accuracy, clarity, and compliance with regulatory expectations
- The Science and Compliance Specialist serves as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs and controlled documents, and supporting production teams through troubleshooting, process optimization, and documentation accuracy.
- The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem-solving methods to identify root causes, maintain accurate cGMP compliant records, and drive effective CAPA implementation.
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- BS degree, preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience
- 2+ years technical writing experience, preferably in pharmaceutical industry
- Must have knowledge of GMPs and worldwide regulatory agency guidelines.
- Knowledge of applicable CAPA procedures, specifications, regulations and standards
- Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
- Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
- Ability to demonstrate strong leadership skills
- Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
- Ability to utilize enterprise software systems (Veeva)
- Ability to gown in C/D gowning area
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
- 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.