QA Validation Specialist (Fill/Finish)

Role Summary

QA Validation Specialist (Fill/Finish) at Regeneron. Ensure equipment, systems, and processes meet regulatory standards while adhering to manufacturing policies and procedures. Supports the Fill Finish facility in Rensselaer, NY.

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)
• Present in a “pressure test” scenario the technical area they are SME for
• Stay current with industry trends, regulatory requirement updates, and motivate changes and improvements based on trends
• Generate, implement and/or review master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analyze the results of testing and determine the acceptability of results against pre-determined criteria
• Review, edit and approve deviation notifications, deviation 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 both internal and external (regulatory) audits

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; experience by level shown below
  • Assoc 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 or collaborative work capability
• Transparent communication
• Ability to gather and organize information
• Effective time management
• Continuous improvement mindset

Gowning and Environment

• Full cleanroom attire, including gown, facemask, hairnet, safety glasses, gloves, and booties; use of sanitizing agents during gowning (e.g., IPA)
• Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire