Principal Sterility QA Validation Lead

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 92,000 - 151,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Principal QA Validation Specialist, Sterility, to lead the QA Validation team for utilities, cleanrooms and EMPQ at our internal fill/finish facility.

You will ensure regulatory compliance, strengthen contamination control, and drive qualification documentation to support commercial production. You will supervise a specialist and consultants, oversee audits, change controls, and risk management activities, and participate in Annex 1 gap assessments to

Qualifications

• 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 Quality Risk Management (QRM) deliverables including Hazard Analysis and Critical Control Points (HACCP) assessments and continuous trending/reporting
• Lead investigations of contamination events associated with 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 and develop a specialist and a team of consultants to meet project milestones and deliver qualification/documentation deliverables
• Establish processes that ensure compliance with regulatory requirements, including participation in Annex 1 gap assessments
• Influence the creation and revision of local/global policies, standards, procedures, and business processes to align with industry best practices
• Demonstrated experience in a cGMP-regulated environment, including validation, inspection and audit readiness
• Possesses strong cross-functional collaboration and communication skills

Responsibilities

• Lead validation and 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 trending/reporting
• Lead investigations of contamination events related to environmental monitoring in cleanrooms
• Qualify critical utilities: WFI, pharmaceutical air, AHUs, clean steam generators, nitrogen systems
• Oversee a team of specialists and consultants to meet milestones and deliver documentation

Skills

Utilities qualification/validation

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Principal QA Validation Specialist, Sterility, to lead the QA Validation team for utilities, cleanrooms and EMPQ at our internal fill/finish facility.

You will ensure regulatory compliance, strengthen contamination control, and drive qualification documentation to support commercial production. You will supervise a specialist and consultants, oversee audits, change controls, and risk management activities, and participate in Annex 1 gap assessments to