Principal QA Validation Specialist (Fill Finish)

About the role

Regeneron is seeking a Principal QA Validation Specialist to join the Quality Assurance department. They will lead the utilities and EMPQ team for the 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.

A typical day might include

• 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

This role might be for you if you have

• 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

Gowning and environment

• Full cleanroom attire (examples may include: laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences
• 8+ years of relevant experience
• Experience in utility and facility qualification/validation is required
• Level is determined based on qualifications relevant to the role
• Must be willing and able to work Monday-Friday, 8am-4:30pm