Principal QA Validation Specialist (Fill Finish)
Regeneron Pharmaceuticals, Inc, East Greenbush, NY, United States
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
Qualifications
Demonstrated experience in a cGMP-regulated environment, including validation, inspection and audit readiness
Possesses strong cross‑functional collaboration and communication skills
Have proven ability to lead teams in a fast‑paced, dynamic environment
Are able to gown and work in manufacturing areas as required
Gowning and Environment
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
To be considered for the Principal QA Validation Specialist you must be willing and able to work Monday‑Friday, 8am‑4:30pm. 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. Level is determined based on qualifications relevant to the role.
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; 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
Qualifications
Demonstrated experience in a cGMP-regulated environment, including validation, inspection and audit readiness
Possesses strong cross‑functional collaboration and communication skills
Have proven ability to lead teams in a fast‑paced, dynamic environment
Are able to gown and work in manufacturing areas as required
Gowning and Environment
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
To be considered for the Principal QA Validation Specialist you must be willing and able to work Monday‑Friday, 8am‑4:30pm. 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. Level is determined based on qualifications relevant to the role.
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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