Principal Quality Assurance Validation Specialist
Regeneron Pharmaceuticals
Summary
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.
Job description
When & where
- Location: 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
Discover your role
- 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 teammate as needed
- May manage full-time employees as well as contractors
- Manages projects and prepares status reports
- Other duties assigned by management
The environment and physical rhythms of the role
- 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)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
This role requires
- 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
- Experience with laboratory or analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP environment is preferred
- Previous people leadership/supervisory experience preferred
Requirements
- BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education
- 8+ years of relevant experience for Principal level
- 10+ years of relevant experience for Staff level
- Experience with laboratory or analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP environment is preferred
- Previous people leadership/supervisory experience preferred
Benefits
- Annual bonuses
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.