QA Validation Specialist (Fill/Finish)
Regeneron
Full-time
On-site
East Greenbush, NY
Operations
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Role Summary
QA Validation Specialist (Fill/Finish) responsible for ensuring equipment, systems, and processes meet regulatory standards and manufacturing policies at the Fill Finish facility in Rensselaer, NY. Supports validation activities across the Fill Finish line, including equipment qualification and process validation for syringes, vials, lyophilization, inspection, assembly, packaging, serialization, and related operations.
Responsibilities
- Monitor compliance, analyze failures, and assess corrective actions
- Present project and program status and metrics to Senior Management; act as 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 they are SME for
- Stay current with industry trends and regulatory updates; motivate changes based on trends
- Generate, implement, and/or review master and completed qualification and validation protocols, summary reports, and related data for conformance to regulations and SOPs
- Analyze testing results and determine acceptability against predefined 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 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 internal and external (regulatory) audits
Qualifications
- BS/BA in Engineering, Chemistry, or Life Sciences; level determined by qualifications
- Associate QA Validation Specialist: 0-2+ years
- QA Validation Specialist: 2+ years
- Sr QA Validation Specialist: 5+ years
- May substitute proven experience for education requirement
Skills
- Independent and team work capability
- Transparent communication
- Ability to gather and organize information
- Effective time management
- Continuous improvement mindset
Education
- BS/BA in Engineering, Chemistry, or Life Sciences (as above)
Additional Requirements
- Gowning and Cleanroom Environment: Full cleanroom attire and related safety practices
- Regulatory and audit readiness; ability to present during audits