QA Validation Specialist (Fill/Finish)

Regeneron Pharmaceuticals • Rensselaer, NY

3d • Onsite

About The Position

Our Fill Finish QA Validation team is hiring. As the QA Validation Specialist, you will ensure equipment, systems, and processes meet regulatory standards while adhering to company manufacturing policies and procedures. This role will support our Fill Finish facility in Rensselaer, NY. Equipment Includes: Syringe and Vial Fillers, Lyophilizer, Semi-Automatic and Automatic Inspection, Assembly Machines, Packaging Machines, Serialization, Case Packer and Palletizer In this role, a typical day might include the following: 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 Manage and drives projects and prepares status reports May present at both internal and external (regulatory) audits This role may be for you if you: Are able to work independently or as part of a team Have ability to communicate with transparency Can gather and organize information Have effective time management skills Seek to identify continuous improvement needs Gowning and Environment Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA) Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Requirements

• Are able to work independently or as part of a team
• Have ability to communicate with transparency
• Can gather and organize information
• Have effective time management skills
• Seek to identify continuous improvement needs
• BS/BA in Engineering, Chemistry, or Life Sciences
• QA Validation Specialist: 2+ years experience
• Sr QA Validation Specialist: 5+ years experience
• May substitute proven experience for education requirement.

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
• Manage and drives projects and prepares status reports
• May present at both internal and external (regulatory) audits

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level