Job Summary

The Senior CQV Engineer leads commissioning, qualification, and validation (CQV) activities for GMP manufacturing equipment, facilities, utilities, automation systems, and infrastructure . This role ensures systems are designed, installed, tested, and maintained in compliance with cGMP and regulatory requirements while supporting capital projects, facility expansions, and operational readiness initiatives.

Responsibilities

• Lead CQV activities for GMP equipment, utilities, facilities, automation systems, and infrastructure.
• Develop and execute validation documentation, including plans, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and summary reports.
• Author, review, and approve SOPs, change controls, deviations, CAPAs, and validation lifecycle documents.
• Coordinate commi...