Aseptic Equipment Lead (3rd Shift)
Simtra BioPharma Solutions(10 days ago)
About this role
Simtra BioPharma Solutions is a CDMO specializing in sterile injectable products, supporting biologics, small molecules, cytotoxics, and vaccines. The Aseptic Equipment Lead oversees the setup, performance, and optimization of an aseptic filling line during the assigned shift, ensuring production success and product quality in a cGMP sterile manufacturing environment. This role interacts with Engineering, Maintenance, and Operations to support continuous improvement and inspection readiness.
Required Skills
- Aseptic Gowning
- Equipment Troubleshooting
- Mechanical Aptitude
- Line Optimization
- Root Cause Analysis
- Trend Analysis
- Process Improvement
- Operator Training
- Microsoft Excel
- Enterprise Systems
Qualifications
- High School Diploma or GED
- Grade A/B Aseptic Gowning Certification
- Operator Qualification/Media Fill
About Simtra BioPharma Solutions
simtra.comSimtra BioPharma Solutions is a contract development and manufacturing organization (CDMO) focused on sterile injectable products. They offer end-to-end services — from formulation and analytical development through aseptic fill/finish, packaging, quality and regulatory support — to advance programs from clinical stages to commercial supply. Simtra emphasizes flexible product delivery options and a compliance-driven approach to meet biopharma partners’ timelines and manufacturing requirements.
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