Principal QA Validation Specialist, Fill Finish
Regeneron
August 10, 2026
On-site
East Greenbush, NY
Operations
Discover Your Role
- Lead validation and serve as SME for utilities and environmental qualification; assess change controls, review CAPAs/NOEs, approve documents, and lead audits
- Plan and execute cleanroom qualifications and requalification; oversee EMPQ for filling line clean air equipment
- Drive QRM deliverables including HACCP assessments and continuous trending/reporting
- Lead investigations of contamination events linked to environmental monitoring in cleanrooms and clean air equipment
- Qualify critical utilities: Water for Injection (WFI), pharmaceutical air, AHUs, clean steam generators, and nitrogen distribution systems
- Manage/develop a specialist and consultants to meet milestones and deliver qualification/documentation
- Establish processes ensuring regulatory compliance, including participation in Annex 1 gap assessments
- Influence creation/revision of local/global policies, standards, procedures, and business processes
- Demonstrated experience in a cGMP-regulated environment with validation, inspection, and audit readiness
- Strong cross-functional collaboration and communication skills
This Role Requires
- BS/BA in Engineering, Chemistry, or Life Sciences and 8+ years of relevant experience
- Experience in utility and facility qualification/validation
The Environment And Physical Rhythms Of The Role
- Full cleanroom attire; remove jewelry/makeup/nail adornments when wearing cleanroom attire
Application Instructions
- Apply now.
- Lead validation and serve as SME for utilities and environmental qualification; assess change controls, review CAPAs/NOEs, approve documents, and lead audits
- Plan and execute cleanroom qualifications and requalification; oversee EMPQ for filling line clean air equipment
- Drive QRM deliverables including HACCP assessments and continuous trending/reporting
- Lead investigations of contamination events linked to environmental monitoring in cleanrooms and clean air equipment
- Qualify critical utilities: Water for Injection (WFI), pharmaceutical air, AHUs, clean steam generators, and nitrogen distribution systems
- Manage/develop a specialist and consultants to meet milestones and deliver qualification/documentation
- Establish processes ensuring regulatory compliance, including participation in Annex 1 gap assessments
- Influence creation/revision of local/global policies, standards, procedures, and business processes
- Demonstrated experience in a cGMP-regulated environment with validation, inspection, and audit readiness
- Strong cross-functional collaboration and communication skills
This Role Requires
- BS/BA in Engineering, Chemistry, or Life Sciences and 8+ years of relevant experience
- Experience in utility and facility qualification/validation
The Environment And Physical Rhythms Of The Role
- Full cleanroom attire; remove jewelry/makeup/nail adornments when wearing cleanroom attire
Application Instructions
- Apply now.