Senior QA Validation Specialist - GMP Equipment Validation

BioSpace; City of Saratoga Springs (NY); Sur place; USD 62 000 - 129 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) match

Paid time off

Life insurance

Résumé du poste

Regeneron is hiring a QA Validation Specialist to validate laboratory and analytical equipment at the Saratoga Springs site within a highly automated, digitally integrated biologics environment. The role supports manufacturing equipment and utilities validation as needed.

You will generate and review qualification protocols, analyze results, troubleshoot issues, and coordinate with QC, Manufacturing Science and outside vendors to ensure compliant validation across GMP processes.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences or equivalent experience.
• 0-2+ years of relevant experience for Associate QA Validation Specialist; 4+ years for QA Validation Specialist; 6+ years for Sr. QA Validation Specialist.
• Experience with laboratory or analytical instrumentation in a GMP environment preferred.

Responsabilités

• Generates, executes, and reviews qualification and validation protocols, summary reports, and associated data for laboratory and analytical equipment (e.g., HPLC, GC, balances, spectrophotometers, incubators).
• Analyzes testing results and determines acceptability against pre-determined criteria.
• Investigates and troubleshoots issues with laboratory equipment and recommends improvements.
• Reviews, edits, and approves deviation notifications, deviations investigations, and corrective actions.
• Reviews, edits, and approves change controls, SOPs, reports, and other documentation.
• Provides secondary support for qualification of manufacturing equipment and utilities as needed.
• Coordinates with Quality Control, Manufacturing Science, and outside contractors/vendors to complete validation tasks.
• Trains, advises and mentors teammates; may oversee contingent workers.
• Manages projects and prepares status reports.
• Other duties assigned by management.

Formation

BS/BA in Engineering, Chemistry, or Life Sciences

Outils

HPLC

GC

Balances

Spectrophotometers

Incubators

Description du poste

Regeneron is hiring a QA Validation Specialist to validate laboratory and analytical equipment at the Saratoga Springs site within a highly automated, digitally integrated biologics environment. The role supports manufacturing equipment and utilities validation as needed.

You will generate and review qualification protocols, analyze results, troubleshoot issues, and coordinate with QC, Manufacturing Science and outside vendors to ensure compliant validation across GMP processes.