Regeneron · 5 days ago
QA Validation Specialist (Fill Finish)
East Greenbush, NY
Full-time
Onsite
Mid, Senior Level
$66K/yr - $127K/yr
5+ years expRegeneron is a leading biotechnology company focused on developing medicines for serious diseases. The Senior QA Validation Specialist will ensure that equipment, systems, and processes meet regulatory standards while supporting the Fill Finish facility.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Monitor compliance, analyze failures, and assess corrective actions
Presents 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)
Must be able to present in a “pressure test” scenario the technical area they are SME for
Stays current with industry trends, regulatory requirement updates, and motivates changes and improvements based on trends
Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions
Reviews, edits and approves change controls, SOPs, reports and other documentation
Coordinates with other departments or outside contractors/vendors to complete validation tasks
Collaborates with functional departments to resolve issues
Trains/advises less experienced Specialists
May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines
Manage and drives projects and prepares status reports
May present at both internal and external (regulatory) audits
May manage full time employees and/or contingent workers
Performs other duties assigned by Management
Qualification
Required
BS/BA in Engineering, Chemistry, or Life Sciences
QA Validation Specialist: 2+ years experience
Sr QA Validation Specialist: 5+ years experience
Ability to work independently or as part of a team
Ability to communicate with transparency
Gathers and organizes information
Effective time management skills
Seeks to identify continuous improvement needs
Benefits
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
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-13
2026-01-09
Company data provided by crunchbase