Principal QA Validation Specialist, Fill Finish

Location: Rensselaer, New York, United States

Work model: Monday-Friday, 8am-4:30pm

About the Role

Lead the utilities and EMPQ team for our internal fill finish facility, overseeing qualification of utilities, cleanrooms, and filling lines critical to commercial production. Ensure regulatory compliance, strengthen the contamination control strategy, and drive key licensure activities.

Responsibilities

• 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 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

Requirements

• Demonstrated experience in a cGMP-regulated environment, including validation, inspection, and audit readiness
• Strong cross-functional collaboration and communication skills
• BS/BA in Engineering, Chemistry, or Life Sciences and 8+ years of relevant experience
• Experience in utility and facility qualification/validation

Work Environment

• Gowning: Full cleanroom attire (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents such as IPA during gowning process)
• Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g., medical, dental, vision, life, and disability), paid time off, and family support benefits.

Pay

Salary Range (annually): $92,200.00 - $150,600.00