QA Validation Engineer for GMP Biologics

Regeneron Pharmaceuticals; Saratoga Springs (UT); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals in Saratoga Springs, NY is hiring QA Validation Specialists to join our highly automated drug substance facility. You will generate, execute, and review qualification and validation protocols for laboratory equipment (HPLC, GC, balances, spectrophotometers) to ensure regulatory compliance.

Responsibilities include analyzing results, approving deviations and change controls, coordinating with QC, Manufacturing Science, and vendors, and mentoring teammates.

Qualifications

• Experience validating and qualifying laboratory instrumentation in GMP environments.
• Familiarity with HPLC, GC, balances and spectrophotometers.
• Ability to analyze results and determine acceptance against criteria.

Responsibilities

• Generates, executes, and reviews qualification/validation protocols and reports for lab equipment.
• Analyzes testing results and determines acceptability against criteria.
• Investigates problems and recommends changes or improvements.
• Reviews deviation notifications, investigations, and corrective actions.
• Provides secondary support for manufacturing equipment validation.
• Coordinates with QC, Manufacturing Science and external vendors to complete validation tasks.
• Trains and mentors teammates; may oversee contingent workers.
• Manages projects and prepares status reports.

Skills

GMP experience

Lab instrumentation

Validation protocols

Troubleshooting

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Job description

Regeneron Pharmaceuticals in Saratoga Springs, NY is hiring QA Validation Specialists to join our highly automated drug substance facility. You will generate, execute, and review qualification and validation protocols for laboratory equipment (HPLC, GC, balances, spectrophotometers) to ensure regulatory compliance.

Responsibilities include analyzing results, approving deviations and change controls, coordinating with QC, Manufacturing Science, and vendors, and mentoring teammates.