Simtra BioPharma Solutions
Aseptic Equipment Lead (Weekend PM)
Bloomington, Indiana, United States
Sponsorship not specifiedDetected 12 days ago
ExcelGMPMicrosoft 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 troubleshooting efforts by investigating complex issues, identifying root causes, and implementing effective, long‑term solutions.
- Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness.
- Partner with Line Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall team performance.
- Maintain Grade A/B aseptic gowning certification and successfully complete operator qualification/media fill requirements.
- As an Aseptic Equipment Lead (AEL), you'll be at the heart of our sterile manufacturing operations.
- You'll own the setup, performance, and optimization of a key aseptic filling line during your shift-making a direct impact on production success, product quality, and team efficiency.
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- At least 3 years of manufacturing experience.
- Strong mechanical aptitude and the ability to troubleshoot in a hands‑on, equipment‑focused environment.
- Ability to lift up to 50 lbs.
- Ability to stand and/or walk for extended periods.
Nice to have
- Proficiency in Microsoft Word, Excel, and Outlook, plus the ability to learn enterprise systems such as Veeva, D365, and Blue Mountain.
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.