Quality Assurance Validation Specialist

Regeneron Pharmaceuticals • Saratoga Springs, NY

5d • Onsite

About The Position

Regeneron is hiring multiple Quality Assurance Validation Specialists for its new highly automated drug substance manufacturing facility. The role primarily 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 is initially based in Rensselaer, New York, and will permanently be based in Saratoga Springs, New York. The work schedule 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 role requires full cleanroom attire, which may include laundered undergarments, a gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents such as IPA. Jewelry, makeup, and nail adornments must be removed when wearing cleanroom attire. The position level—Associate, Specialist, or Senior Specialist—will be determined based on experience.

Requirements

• BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience may substitute for education.
• Associate QA Validation Specialist: 0–2+ years of relevant experience.
• QA Validation Specialist: 4+ years of relevant experience.
• Senior QA Validation Specialist: 6+ 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, and spectrophotometers, in a GMP environment is preferred.

Responsibilities

• Generate, execute, and/or review master and completed qualification and validation protocols, summary reports, and associated data for laboratory and analytical equipment, including HPLC, GC, balances, spectrophotometers, and incubators.
• Analyze testing 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, deviation 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 validation tasks with Quality Control, Manufacturing Science, outside contractors and vendors, including Automation and Computer Systems Assurance.
• Train, advise, and mentor teammates as needed.
• Oversee contingent workers as required.
• 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.

What This Job Offers

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