Aseptic Officer
Amgen(1 month ago)
About this role
The Aseptic Officer provides technical leadership and oversight of aseptic operations within a multi-product drug product manufacturing facility, ensuring compliance with cGMP and sterility assurance standards. The role owns the media program for an isolator-based filling line and partners cross-functionally with Quality, Validation, and Engineering. The position supports contamination control initiatives and represents Manufacturing during inspections.
Required Skills
- Aseptic Technique
- Media Fill
- Contamination Control
- Sterility Assurance
- Isolator Operations
- SOP Authoring
- Training
- Data Trending
- Regulatory Compliance
- Root Cause
+2 more
Qualifications
- Doctorate Degree
- Master’s Degree
- Bachelor’s Degree
- Associate’s Degree
- High School Diploma / GED
- Bachelor’s or Master’s in Microbiology or Life Sciences
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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