Regeneron · 2 weeks ago
Principal QA Validation Specialist (CSV)
Troy, NY
Full-time
Onsite
Senior Level, Lead/Staff
$79K/yr - $151K/yr
8+ years expRegeneron is seeking a Principal QA Validation Specialist to support the validation and qualification of computer systems within IOPS. The role involves planning, coordinating, and participating in compliant computer system validation processes and ensuring adherence to regulatory and manufacturing standards.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Generates, executes and/or reviews master and completed computer system(s) 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 settles acceptability of results against pre-determined criteria
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
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
Trains/advises less experienced Specialists
Leads projects and prepares status reports
May be required to oversee contingent workers
Qualification
Required
BS/BA in Engineering, Chemistry, Life Sciences, Computer Science, IT or related field
5+ years of experience for Sr. QA Validation Specialist
8+ years of experience for Principal QA Validation Specialist
Knowledge in GAMP, 21 CFR PART 11, Annex 11
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
2026-01-09
2026-01-08
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