Senior Quality Assurance Validation Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Join our Quality Assurance team as a Senior QA Validation Specialist and contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

About the role

You will validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow, and implement company manufacturing standards, policies, and procedures.

Responsibilities

• Generates, executes, and/or reviews master and completed qualification and validation protocols, summary reports, and associated data 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 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
• Coordinates with other departments or outside contractors/vendors to complete validation tasks
• Executes real-world and simulated transport studies, including gross-damage visual inspections, pallet configuration assessments, and qualification of secondary and tertiary packaging materials
• Conducts temperature mapping for controlled environments and distribution lanes
• Programs and deploys instrumentation to capture vibration and shock profiles; analyzes data to inform packaging design and handling recommendations
• Programs humidity and pressure sensors and interprets datasets to support test plans and root-cause analysis
• Applies ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification
• Performs small-parcel and palletized-load qualifications, including test planning, execution, and reporting

Gowning and Environment

• Full cleanroom attire (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents such as IPA during gowning)
• Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire

Requirements

• B.S. in life sciences or related field; proven experience may substitute for education requirement
• QA Validation Specialist: 4+ years of experience
• Sr. QA Validation Specialist: 6+ years of experience
• Level will be determined based on experience

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture, and well-being programs (including physical & mental health)
• 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
  • Insurance benefits (e.g., medical, dental, vision, life, and disability)
  • Paid time off
  • Family support benefits

Pay

Salary Range (annually): $67,400.00 - $128,700.00

Schedule

Monday-Friday, 8am-4:30pm