Regeneron's QA Fill Finish Validation team is looking to validate and qualify equipment, systems, and processes in compliance with regulatory standards to support their newly constructed Fill Finish Facility in Upstate NY
Requirements
- Expertise in validation processes including automated/semi-automated visual inspection and finished goods handling
- Ability to communicate with transparency
- Knowledge of Equipment Qualification, Drug Product Filling Validation, and Automated/Semi-Automated Visual Inspection
- Experience with Syringe/Vial Fillers, Inspection Machines, Packaging Machines, and Finished Goods handling systems
- Familiarity with regulatory standards and compliance
- Strong problem-solving skills
- Experience with master and complete qualification validation protocols, reports, SOPs, and change controls
Responsibilities
- Lead validation efforts for equipment, processes, and systems (including IQ, OQ, PQ)
- Act as a Technical SME (Subject Matter Expert) 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
- Generate, review, and approve master and complete qualification validation protocols, reports, SOPs, and change controls
- Reviews, edits and approves 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 both internal and external (regulatory) audits
Other
- BS/BA in Engineering, Chemistry, or Life Sciences
- 5+ years of experience for Sr QA Validation Specialist, 8+ years for Principal QA Validation Specialist, and 10+ years for Staff QA Validation Specialist
- Strong communication, time management, and problem-solving skills
- Ability to work in a fast-paced, innovative environment
- Must be able to present in a 'pressure test' scenario the technical area they are SME for
