IQ/OQ/PQ Validation Specialist for GMP Manufacturing

Katalyst CRO; Richmond (VA); Sur place; USD 83 000 - 145 000; Plein temps

Résumé du poste

Katalyst CRO is seeking a hands-on Equipment Qualification & Process Validation Contractor to support the Enterprise Quality Change Management & Systems organization. You will execute IQ/OQ/PQ for manufacturing equipment, processes, and materials in a regulated environment, delivering right-first-time qualification deliverables on the factory floor.

Reporting to the Manager, you will author protocols and reports, manage deviations with full traceability, and coordinate activities with

Qualifications

• Bachelor's degree in a technical discipline or equivalent experience.
• 5+ years of IQ/OQ/PQ and process validation experience in GMP or regulated manufacturing.
• Experience with protocol writing, execution, reports, deviations, and traceability.
• Proficiency with eQMS (TrackWise or similar), document management systems, and MS Office/Excel.
• CQE, CQA, ASQ, or similar certification preferred.

Responsabilités

• Execute and close IQ/OQ/PQ protocols for manufacturing equipment and systems.
• Author protocols, qualification reports, and GMP-compliant documentation.
• Document deviations/discrepancies and maintain full record traceability.
• Coordinate qualification activities with Manufacturing, Engineering, Quality, and Project teams.
• Support change control, documentation remediation, and record management.
• Execute qualification activities on the factory floor around production schedules.

Connaissances

IQ/OQ/PQ

Technical Writing

Cross-functional coordination

Formation

Bachelor's degree in a technical discipline

Outils

eQMS TrackWise

MS Office/Excel

Description du poste

Katalyst CRO is seeking a hands-on Equipment Qualification & Process Validation Contractor to support the Enterprise Quality Change Management & Systems organization. You will execute IQ/OQ/PQ for manufacturing equipment, processes, and materials in a regulated environment, delivering right-first-time qualification deliverables on the factory floor.

Reporting to the Manager, you will author protocols and reports, manage deviations with full traceability, and coordinate activities with