Principal QA Validation Specialist (Fill/Finish)
Regeneron
Full-time
Remote friendly (East Greenbush, NY)
United States
Operations
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Role Summary
Principal QA Validation Specialist (Fill/Finish) in Regeneron’s QA Fill Finish Validation team to validate and qualify equipment, systems, and processes in compliance with regulatory standards. Support the Fill Finish Facility in Upstate NY and contribute to a fast-paced, innovative environment.
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.
- 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 Validations Specialists and/or contingent workers to meet goals and deadlines.
- May present at internal and external (regulatory) audits.
Qualifications
- Required: BS/BA in Engineering, Chemistry, or Life Sciences; 8+ years for Principal level (or equivalent) with progressive QA validation experience; or substitute proven experience for the education requirement.
- Role levels and experience: QA Validation Specialist: 2+ years; Sr QA Validation Specialist: 5+ years; Principal QA Validation Specialist: 8+ years.
Skills
- Expertise in validation processes including automated/semi-automated visual inspection and finished goods handling.
- Strong communication, time management, and problem-solving skills.
- Ability to communicate with transparency and drive process improvements.
Education
- BS/BA in Engineering, Chemistry, or Life Sciences (or equivalent experience).
Additional Requirements
- May supervise and assign work to team members and contingent workers.
- May participate in internal and regulatory audits.