Regeneron
QA Validation Specialist (Fill/Finish)
Our Fill Finish QA Validation team is hiring. As the QA Validation Specialist, you will ensure equipment, systems, and processes meet regulatory standards while adhering to company manufacturing policies and procedures. This role will support our Fill Finish facility in Rensselaer, NY.
Equipment
Syringe and Vial Fillers
Lyophilizer
Semi‑Automatic and Automatic Inspection
Assembly Machines
Packaging Machines
Serialization
Case Packer and Palletizer
Typical Day / Responsibilities
Monitor compliance, analyze failures, and assess corrective actions.
Present project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g., Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control).
Present in a “pressure test” scenario the technical area you are SME for.
Stay current with industry trends, regulatory requirement updates, and motivate changes and improvements based on trends.
Generate, implement and/or review master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
Analyze the results of testing and determine the acceptability of results against pre‑determined criteria.
Review, edit and approve deviation notifications, deviation investigations, and corrective actions.
Review, edit and approve change controls, SOPs, reports and other documentation.
Coordinate with other departments or outside contractors/vendors to complete validation tasks.
Collaborate with functional departments to resolve issues.
Manage and drive projects and prepare status reports.
May present at both internal and external (regulatory) audits.
Why This Role May Be For You
Able to work independently or as part of a team.
Capability to communicate with transparency.
Skill to gather and organize information.
Effective time management skills.
Seek to identify continuous improvement needs.
Gowning and Environment
Full cleanroom attire (examples 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 To be considered, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and meet the following experience levels:
Associate QA Validation Specialist: 0–2+ years
QA Validation Specialist: 2+ years
Senior QA Validation Specialist: 5+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
Salary Range (annually) $59,700.00 – $126,800.00
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industry Biotechnology
Benefits We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
EEO 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 Traveller 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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Equipment
Syringe and Vial Fillers
Lyophilizer
Semi‑Automatic and Automatic Inspection
Assembly Machines
Packaging Machines
Serialization
Case Packer and Palletizer
Typical Day / Responsibilities
Monitor compliance, analyze failures, and assess corrective actions.
Present project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g., Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control).
Present in a “pressure test” scenario the technical area you are SME for.
Stay current with industry trends, regulatory requirement updates, and motivate changes and improvements based on trends.
Generate, implement and/or review master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
Analyze the results of testing and determine the acceptability of results against pre‑determined criteria.
Review, edit and approve deviation notifications, deviation investigations, and corrective actions.
Review, edit and approve change controls, SOPs, reports and other documentation.
Coordinate with other departments or outside contractors/vendors to complete validation tasks.
Collaborate with functional departments to resolve issues.
Manage and drive projects and prepare status reports.
May present at both internal and external (regulatory) audits.
Why This Role May Be For You
Able to work independently or as part of a team.
Capability to communicate with transparency.
Skill to gather and organize information.
Effective time management skills.
Seek to identify continuous improvement needs.
Gowning and Environment
Full cleanroom attire (examples 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 To be considered, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and meet the following experience levels:
Associate QA Validation Specialist: 0–2+ years
QA Validation Specialist: 2+ years
Senior QA Validation Specialist: 5+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
Salary Range (annually) $59,700.00 – $126,800.00
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industry Biotechnology
Benefits We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
EEO 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 Traveller 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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