Principal QA Validation Specialist (Fill Finish)

About the role

Regeneron is currently seeking a Principal QA Validation Specialist to join our Quality Assurance department. They will lead the utilities and EMPQ team for 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: WFI (Water for Injection), 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
• Proven ability to lead teams in a fast-paced, dynamic environment
• Ability to gown and work in manufacturing areas as required

Qualifications

To be considered for the Principal QA Validation Specialist, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and 8+ years of relevant experience. Experience in utility and facility qualification/validation is required.

Skills

Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire. Ability to work in full cleanroom attire, including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA.

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

Schedule

You must be willing and able to work Monday-Friday, 8am-4:30pm.