Regeneron
QA Validation Specialist (Fill Finish)
Work at Regeneron in Rensselaer, NY. The Senior QA Validation Specialist ensures equipment, systems, and processes meet regulatory standards while adhering to company manufacturing policies and procedures.
Responsibilities
Ensure equipment, including syringe and vial fillers, lyophilizer, inspection machines, assembly & packaging machines, serialization, case packer, and palletizer, satisfy quality and regulatory standards.
Monitor compliance, analyze failures, and assess corrective actions.
Present project and program status metrics to Senior Management.
Act as Technical Subject Matter Expert (SME) in at least one area such as Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, or CN/PN Change Control.
Demonstrate technical expertise in pressure‑test scenarios.
Stay current with industry trends and regulatory updates, motivating changes and improvements.
Generate, implement, and review qualification and validation protocols, summary reports, and data for conformance to regulations, SOPs, and specifications.
Analyze testing results to determine acceptability against predetermined criteria.
Review, edit, and approve deviation notifications, investigations, and corrective actions.
Review, edit, and approve change controls, SOPs, reports, and other documentation.
Coordinate with other departments or external contractors/vendors to complete validation tasks.
Collaborate with functional departments to resolve issues.
Train and advise less experienced specialists.
Supervise, provide direction, and assign work to Validation Specialists and/or contingent workers.
Manage and drive projects and prepare status reports.
Participate in internal and external regulatory audits.
Manage full‑time employees and/or contingent workers as required.
Perform additional duties as assigned by management.
Qualifications
Bachelor’s degree (BS/BA) in Engineering, Chemistry, Life Sciences, or related field.
2+ years of QA Validation experience for entry‑level specialist, 5+ years for senior level.
Ability to work independently or as part of a team.
Transparent communication and effective information gathering.
Strong time‑management skills and identification of continuous improvement opportunities.
Work Environment & Gowning Requirements
Full cleanroom attire (laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes/booties, latex gloves, sanitizing agents). Must remove jewelry, makeup, and nail adornments.
Salary Range (annually) $66,400.00 – $126,800.00
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance – Biotechnology
Benefits Regeneron offers inclusive benefits such as health and wellness programs (medical, dental, vision, life, disability insurance), fitness centers, 401(k) company match, family support, equity awards, annual bonuses, paid time off, and paid leaves. For additional information, visit the Regeneron benefits website.
Equal Opportunity Statement Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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 for qualified applicants with disabilities.
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Responsibilities
Ensure equipment, including syringe and vial fillers, lyophilizer, inspection machines, assembly & packaging machines, serialization, case packer, and palletizer, satisfy quality and regulatory standards.
Monitor compliance, analyze failures, and assess corrective actions.
Present project and program status metrics to Senior Management.
Act as Technical Subject Matter Expert (SME) in at least one area such as Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, or CN/PN Change Control.
Demonstrate technical expertise in pressure‑test scenarios.
Stay current with industry trends and regulatory updates, motivating changes and improvements.
Generate, implement, and review qualification and validation protocols, summary reports, and data for conformance to regulations, SOPs, and specifications.
Analyze testing results to determine acceptability against predetermined criteria.
Review, edit, and approve deviation notifications, investigations, and corrective actions.
Review, edit, and approve change controls, SOPs, reports, and other documentation.
Coordinate with other departments or external contractors/vendors to complete validation tasks.
Collaborate with functional departments to resolve issues.
Train and advise less experienced specialists.
Supervise, provide direction, and assign work to Validation Specialists and/or contingent workers.
Manage and drive projects and prepare status reports.
Participate in internal and external regulatory audits.
Manage full‑time employees and/or contingent workers as required.
Perform additional duties as assigned by management.
Qualifications
Bachelor’s degree (BS/BA) in Engineering, Chemistry, Life Sciences, or related field.
2+ years of QA Validation experience for entry‑level specialist, 5+ years for senior level.
Ability to work independently or as part of a team.
Transparent communication and effective information gathering.
Strong time‑management skills and identification of continuous improvement opportunities.
Work Environment & Gowning Requirements
Full cleanroom attire (laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes/booties, latex gloves, sanitizing agents). Must remove jewelry, makeup, and nail adornments.
Salary Range (annually) $66,400.00 – $126,800.00
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance – Biotechnology
Benefits Regeneron offers inclusive benefits such as health and wellness programs (medical, dental, vision, life, disability insurance), fitness centers, 401(k) company match, family support, equity awards, annual bonuses, paid time off, and paid leaves. For additional information, visit the Regeneron benefits website.
Equal Opportunity Statement Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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 for qualified applicants with disabilities.
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