Regeneron
Principal QA Validation Specialist (Fill Finish)
Regeneron, East Greenbush, New York, United States
Principal QA Validation Specialist (Fill Finish)
Our QA Fill Finish Validation team is hiring a Principal QA Validation Specialist to validate and qualify equipment, systems, and processes in compliance with regulatory standards. Support our newly constricted Fill Finish Facility in Upstate NY and contribute to a fast‑paced, innovative environment.
Typical Responsibilities
Lead validation efforts for equipment, processes, and systems (including IQ, OQ, PQ).
Act as a Technical SME in areas including Equipment Qualification, Drug Product Filling Validation, and Automated/Semi‑Automated Visual Inspection.
Validate equipment such as Syringe/Vial Fillers, Inspection Machines, Packaging Machines, and Finished Goods handling systems.
Must be able to present in a “pressure test” scenario the technical area they are SME for.
Generate, review, and approve master and complete qualification validation protocols, reports, SOPs, and change controls.
Review, edit and approve deviation notifications, deviation investigations, and corrective actions.
May supervise, provide direction and assign work to Validation Specialists and/or contingent workers to meet goals and deadlines.
May present at both internal and external (regulatory) audits.
Qualification Highlights
Expertise in validation processes including automated/semi‑automated visual inspection and finished goods handling.
Ability to communicate with transparency.
Continuous improvement mindset for process performance.
Strong communication, time management, and problem‑solving skills.
Gowning and Environment
Full cleanroom attire (e.g., 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.
Education & Experience Requirements
BS/BA in Engineering, Chemistry, or Life Sciences.
Senior QA Validation Specialist: 5+ years.
Principal QA Validation Specialist: 8+ years.
Staff QA Validation Specialist: 10+ years.
May substitute proven experience for education requirement; level is based on qualifications relevant to the role.
Benefits We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
Salary Range (annually) $77,600.00 – $173,400.00
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Regeneron Equal Opportunity Employer Statement 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 Travel 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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Typical Responsibilities
Lead validation efforts for equipment, processes, and systems (including IQ, OQ, PQ).
Act as a Technical SME in areas including Equipment Qualification, Drug Product Filling Validation, and Automated/Semi‑Automated Visual Inspection.
Validate equipment such as Syringe/Vial Fillers, Inspection Machines, Packaging Machines, and Finished Goods handling systems.
Must be able to present in a “pressure test” scenario the technical area they are SME for.
Generate, review, and approve master and complete qualification validation protocols, reports, SOPs, and change controls.
Review, edit and approve deviation notifications, deviation investigations, and corrective actions.
May supervise, provide direction and assign work to Validation Specialists and/or contingent workers to meet goals and deadlines.
May present at both internal and external (regulatory) audits.
Qualification Highlights
Expertise in validation processes including automated/semi‑automated visual inspection and finished goods handling.
Ability to communicate with transparency.
Continuous improvement mindset for process performance.
Strong communication, time management, and problem‑solving skills.
Gowning and Environment
Full cleanroom attire (e.g., 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.
Education & Experience Requirements
BS/BA in Engineering, Chemistry, or Life Sciences.
Senior QA Validation Specialist: 5+ years.
Principal QA Validation Specialist: 8+ years.
Staff QA Validation Specialist: 10+ years.
May substitute proven experience for education requirement; level is based on qualifications relevant to the role.
Benefits We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
Salary Range (annually) $77,600.00 – $173,400.00
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Regeneron Equal Opportunity Employer Statement 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 Travel 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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