Principal QA Validation Specialist, Fill Finish

Role: Principal QA Validation Specialist leading utilities and environmental qualification at a fill finish manufacturing site. Responsibilities: oversee qualification of utilities, cleanrooms, and filling lines; serve as SME for validation, assess change controls, review CAPAs, lead audits, and investigations of contamination events; manage validation deliverables for critical utilities such as WFI, pharmaceutical air, AHUs, and nitrogen systems; develop team members and consultants; ensure compliance with regulatory standards, including participation in Annex 1 gap assessments; influence policies and procedures. Requirements: BS/BA in Engineering, Chemistry, or Life Sciences; 8+ years in validation within a cGMP environment; extensive experience in utility and facility qualification/validation; strong cross-functional communication skills. HighValue: deep expertise in utilities validation, environmental qualification, contamination control, and regulatory compliance (GxP, Annex 1); experience with pharmaceutical manufacturing for sterile fill finish; leadership in validation project management. WorkSetup: onsite in Rensselaer, NY, with gowning and cleanroom protocol adherence.