Principal Quality Assurance Validation Specialist

About the Role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are hiring multiple Quality Assurance (QA) Validation Specialists to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. This position validates and qualifies laboratory and analytical equipment in accordance with regulatory requirements, with secondary support for manufacturing equipment and utility validation in a highly automated, digitally integrated biologics environment. This role may have direct reports in the future.

Location & Schedule

Initial: Rensselaer, New York, United States
Permanent: Saratoga Springs, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Other requirements: Occasional flexibility may be requested for on-call schedule/weekend work

Responsibilities

• Generates, executes, and/or reviews master and completed qualification and validation protocols, summary reports, and associated data for laboratory and analytical equipment (e.g., HPLC, GC, balances, spectrophotometers, incubators) 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
• Investigates and troubleshoots problems which occur with laboratory equipment and determines solutions or recommendations for changes and/or improvements
• Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions
• Reviews, edits, and approves change controls, SOPs, reports, and other documentation
• Provides secondary support for qualification of manufacturing equipment and utilities as needed
• Coordinates with Quality Control, Manufacturing Science, and outside contractors/vendors, including Automation and Computer Systems Assurance, to complete validation tasks for a highly automated facility
• Trains, advises and mentors teammates as needed
• May manage full-time employees as well as contractors
• Manages projects and prepares status reports
• Other duties assigned by management

Work Environment

Gowning: Full cleanroom attire (examples may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Requirements: Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education
• Principal QA Validation Specialist: 8+ years of relevant experience
• Staff QA Validation Specialist: 10+ years of relevant experience
• Level will be determined based on experience
• Previous People Leadership/supervisory Experience Preferred
• Experience with laboratory or analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP environment is preferred

Pay

Salary Range (annually): $92,200.00 - $176,000.00