Principal QA Validation Specialist (Fill Finish)
Regeneron, East Greenbush, NY, United States
Regeneron is currently seeking a Principal QA Validation Specialist to join our Quality Assurance department. The role leads the utilities and EMPQ team for the fill‑finish facility, overseeing qualification of utilities, cleanrooms, and filling lines critical to commercial production. Responsibilities include ensuring regulatory compliance, strengthening the contamination control strategy, and driving key licensure activities.
Responsibilities
Lead validation and serve as SME for utilities and environmental qualification, including assessment of change controls, review of CAPAs/NOEs, document approval, and audit leadership.
Plan and execute cleanroom qualifications and re‑qualifications; oversee EMPQ for filling line clean‑air equipment.
Drive QRM deliverables such as HACCP assessments and continuous trending/reporting.
Lead investigations of contamination events related to 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.
Qualifications
Demonstrated experience in a cGMP‑regulated environment, including validation, inspection readiness, and audit experience.
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 Requirements
Full cleanroom attire (laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes, booties, latex gloves and the use of sanitizing agents during gowning such as IPA).
Ability to remove jewelry, make‑up, and nail adornments when wearing cleanroom attire.
Minimum qualifications: BS/BA in Engineering, Chemistry, or Life Sciences; at least 8 years of relevant experience, with a required focus on utility and facility qualification/validation. Shift: Monday‑Friday, 8 a.m. – 4:30 p.m. (on‑site).
Salary range (annually): $92,200.00 – $150,600.00.
Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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Responsibilities
Lead validation and serve as SME for utilities and environmental qualification, including assessment of change controls, review of CAPAs/NOEs, document approval, and audit leadership.
Plan and execute cleanroom qualifications and re‑qualifications; oversee EMPQ for filling line clean‑air equipment.
Drive QRM deliverables such as HACCP assessments and continuous trending/reporting.
Lead investigations of contamination events related to 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.
Qualifications
Demonstrated experience in a cGMP‑regulated environment, including validation, inspection readiness, and audit experience.
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 Requirements
Full cleanroom attire (laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes, booties, latex gloves and the use of sanitizing agents during gowning such as IPA).
Ability to remove jewelry, make‑up, and nail adornments when wearing cleanroom attire.
Minimum qualifications: BS/BA in Engineering, Chemistry, or Life Sciences; at least 8 years of relevant experience, with a required focus on utility and facility qualification/validation. Shift: Monday‑Friday, 8 a.m. – 4:30 p.m. (on‑site).
Salary range (annually): $92,200.00 – $150,600.00.
Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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