Quality Assurance Validation Specialist

Regeneron Pharmaceuticals • Saratoga Springs, UT

1d • $62,355 - $128,700 • Onsite

About The Position

Regeneron is hiring multiple Quality Assurance Validation Specialists for its new highly automated drug substance manufacturing facility in Saratoga Springs. 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 initial location is Rensselaer, New York, with permanent work in Saratoga Springs, New York. The work model is Monday through Friday, 8:00 a.m. to 4:30 p.m., with occasional flexibility potentially 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. The level will be determined based on experience.

Requirements

• A bachelor's degree in Engineering, Chemistry, or Life Sciences; relevant experience may be substituted for education.
• Relevant experience requirements vary by level: Associate QA Validation Specialist requires 0–2+ years; QA Validation Specialist requires 4+ years; Senior QA Validation Specialist requires 6+ years.
• Ability to wear full cleanroom attire, which may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents such as IPA.
• Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire.

Nice To Haves

• Experience with laboratory or analytical instrumentation, such as HPLC, GC, balances, or spectrophotometers, in a GMP environment.

Responsibilities

• Generate, execute, and/or review master and completed qualification and validation protocols, summary reports, and associated data for laboratory and analytical equipment to ensure conformance with regulations, SOPs, specifications, and applicable acceptance criteria.
• Analyze testing results and determine whether they meet predetermined 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 with Quality Control, Manufacturing Science, and outside contractors and vendors, including Automation and Computer Systems Assurance, to complete validation tasks.
• Train, advise, and mentor teammates as needed.
• Oversee contingent workers when required.
• Manage projects and prepare status reports.
• Perform other duties assigned by management.

Benefits

• Annual bonuses or other incentive plans may be included, depending on country and role.
• Equity awards may be included, depending on country and role.
• Pension or retirement benefits may be included, depending on country and role.
• 401(k) company match may be included, depending on country and role.
• Health and wellness programs may be included, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits may include medical, dental, vision, life, and disability coverage, depending on country and role.
• Paid time off may be included, depending on country and role.
• Family support benefits may be included, depending on country and role.

What This Job Offers

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