Position Overview
We are seeking a
Quality Control CQV Engineer
to support the implementation and lifecycle management of computerized systems within a GMP-regulated pharmaceutical/biotech environment. This role is responsible for ensuring that QC laboratory systems and standalone equipment are properly installed, qualified, and maintained in compliance with regulatory and data integrity requirements. The ideal candidate will work both independently and cross-functionally to deliver validation activities from initiation through completion. Key Responsibilities Set up computerized systems (e.g., Empower, standalone PCs, standalone equipment) Qualify computerized systems in accordance with validation requirements Draft, review, approve, and execute validation protocols (via Kneat and/or hardcopy) Prepare and approve validation documents in Kneat and/or Document Management Systems (e.g., Documentum) Draft and revise system configuration SOPs Initiate, manage, and close out change controls and assigne...