Principal Quality Assurance Validation Specialist
About The Position
Regeneron is hiring Quality Assurance Validation Specialists for its highly automated drug substance manufacturing facility. The role 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. The position may have direct reports in the future. The job is initially based in Rensselaer, New York, with a permanent location in Saratoga Springs, New York. The work model is Monday through Friday, 8:00 a.m. to 4:30 p.m.; occasional flexibility may be requested for on-call scheduling or weekend work. The position requires full cleanroom attire and removal of jewelry, makeup, and nail adornments while wearing cleanroom attire.
Requirements
- BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience may substitute for education.
- Principal QA Validation Specialist: 8+ years of relevant experience.
- Ability to wear full cleanroom attire and remove jewelry, makeup, and nail adornments while wearing it.
Nice To Haves
- Experience with laboratory or analytical instrumentation, such as HPLC, GC, balances, or spectrophotometers, in a GMP environment.
- Previous people leadership or supervisory experience.
Responsibilities
- Generate, execute, and/or review master and completed qualification and validation protocols, summary reports, and associated data for laboratory and analytical equipment.
- Analyze test results and determine whether they meet predetermined acceptance criteria.
- Investigate and troubleshoot laboratory equipment problems and determine solutions or recommend changes and improvements.
- Review, edit, and approve deviation notifications, investigations, and corrective actions.
- Review, edit, and approve change controls, SOPs, reports, and other documentation.
- Provide secondary support for qualification of manufacturing equipment and utilities as needed.
- Coordinate with Quality Control, Manufacturing Science, outside contractors and vendors, and Automation and Computer Systems Assurance to complete validation tasks.
- Train, advise, and mentor teammates as needed.
- Manage full-time employees and contractors as applicable.
- Manage projects and prepare status reports.
- Perform other duties assigned by management.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
