Principal QA Validation Specialist (Fill Finish)

Regeneron Pharmaceuticals • Rensselaer, NY

1d • Onsite

About The Position

Regeneron is seeking a Principal QA Validation Specialist to join the Quality Assurance department. This role will lead the utilities and EMPQ team for a fill finish facility. The specialist will oversee the qualification of utilities, cleanrooms, and filling lines essential for commercial production. Key responsibilities include ensuring regulatory compliance, enhancing the contamination control strategy, and driving critical licensure activities.

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.
• BS/BA in Engineering, Chemistry, or Life Sciences.
• 8+ years of relevant experience.
• Experience in utility and facility qualification/validation is required.

Nice To Haves

• Full cleanroom attire (Examples may include: 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).
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire.

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.

Benefits

• Health and wellness programs (including medical, dental, vision, life, and disability insurance)
• Fitness centers
• 401(k) company match
• Family support benefits
• Equity awards
• Annual bonuses
• Paid time off
• Paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees