Job Description

Overview

We are seeking a highly experienced and detail-oriented CQV (Commissioning, Qualification, and Validation) Manager to lead the execution of commissioning qualification, and validation activities at our pharmaceutical manufacturing facility. The CQV Lead Engineer is responsible for ensuring all equipment, computerized systems, facilities, and processes meet regulatory and quality standards (FDA, EMA, ICH) and are in a state of control throughout their lifecycle. The ideal candidate will manage cross-functional projects and work teams, interface with contractors and engineering teams, and drive compliant, efficient validation programs across both new and existing operations.

Responsibilities

CQV Program Oversight

  • Lead the development and execution of CQV plans for facilities, utilities, equipment (FUE), and process systems.
  • Coordinate with engineering, quality, manufacturing teams and IT to...

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