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Posted 8 hours ago
Aseptic Equipment Lead
Simtra BioPharma SolutionsAseptic Equipment Lead (2nd Shift)
Perks & benefits
Medical InsuranceHealth InsurancePaid Leave
Requirements
High school diploma or GED, 3+ years manufacturing experience, Mechanical aptitude, Microsoft Office proficiency
Skills
ManufacturingTroubleshootingGMP
About the role
Responsibilities
- Act as the subject-matter expert for assigned filling lines and supporting systems including component washers, depyrogenation tunnels, and filling machines
- Lead troubleshooting efforts by investigating complex issues and implementing long-term solutions
- Monitor line performance to support Out of Control Limit Reports (OCRs)
- Analyze trends to reduce downtime and improve product yield
- Standardize and train staff on equipment setup and basic troubleshooting
- Partner with Engineering and Operational Excellence teams to champion safety and quality improvements
- Maintain Grade A/B aseptic gowning certification
Requirements
- High school diploma or GED
- At least 3 years of manufacturing experience
- Proficiency in Microsoft Word, Excel, and Outlook
- Ability to learn enterprise systems like Veeva, D365, and Blue Mountain
- Strong mechanical aptitude for hands-on troubleshooting
- Ability to lift up to 50 lbs and stand for extended periods
- Ability to work in Grade A–D controlled cleanroom environments
About the Company
Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring sterile injectable products to market.
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Simtra BioPharma Solutions · Bloomington
