Franklin Lakes, New Jersey
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Today
Responsibilities: Author and execute Master Validation Plans (MVPs), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports in compliance with regulatory and internal standards. Lead validation activities for critical manufacturing processes including: Liquid phase mixing of formulation materials. Lyophilization (freeze-drying). Moulding and sizing of bioabsorbable components. Maintain and own Process FMEA (pFMEA) documentation and risk management files in
Full-time