Biomanufacturing Validation Engineer
6 days ago
Required Experience:
- Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry;
- Minimum 2 years process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction;
- Presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach;
- SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection;
- Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
Desirable but not essential:
- Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI;
- Clean Utilities and HVAC system Qualification;
- New facility brown/ green field facility introduction experience, or training & developing a team within a commercial manufacturing environment.
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