Quality Assurance Validation Specialist

Regeneron is seeking Quality Assurance Validation Specialists to qualify laboratory and analytical equipment at a new automated biologics manufacturing facility in Saratoga Springs. The role involves developing and executing validation protocols, analyzing test results, investigating equipment issues, and coordinating with cross-functional teams in a regulated environment.

Responsibilities

• Generate, execute, and review qualification and validation protocols and summary reports for laboratory and analytical equipment
• Analyze testing results and determine acceptability against established criteria and regulatory requirements
• Investigate equipment problems, troubleshoot issues, and recommend solutions or improvements
• Review and approve deviation notifications, change controls, and associated documentation
• Coordinate validation tasks with Quality Control, Manufacturing Science, vendors, and automation specialists

Requirements

• Bachelor's degree in Engineering, Chemistry, or Life Sciences; relevant experience may substitute
• 0-2+ years relevant experience for Associate level; 4+ years for Specialist level; 6+ years for Senior level
• Experience with laboratory instrumentation such as HPLC, GC, balances, or spectrophotometers
• GMP environment experience preferred
• Ability to work in cleanroom attire and full-time on-site Monday-Friday schedule
• Occasional on-call or weekend work flexibility as needed

Compensation: $62,355.00 - $128,700.00 annually