CQV Manager

Higashine, Yamagata N/a

Posted: 04/09/2026 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 627006 Is job remote?: Hybrid Country: Japan

Job Description

CQV Manager (Commissioning, Qualification & Validation)
About the Role

We are supporting a large-scale greenfield pharmaceutical manufacturing project and are seeking an experienced CQV Manager to lead commissioning, qualification, and validation activities across the project lifecycle.

This role will oversee CQV strategy, execution, and compliance, working closely with engineering, EPC contractors, and cross-functional project teams to ensure timely and high-quality delivery.
Key Responsibilities
  • Lead and manage all CQV activities across the project lifecycle
  • Develop and execute CQV strategy, plans, and reporting aligned to project requirements
  • Oversee EPC contractor deliverables, ensuring alignment with project scope, timelines, and quality standards
  • Review and manage engineering documentation (PFDs, P&IDs, layouts, equipment specs, etc.)
  • Ensure compliance with GMP, GEP, and validation standards across all systems
  • Act as SME for validation strategy, including computerized systems and automation
  • Coordinate qualification and validation activities, ensuring documentation and traceability
  • Manage project interfaces across engineering, quality, and operations teams
  • Monitor project progress, identify risks, and implement corrective actions
  • Support inspections, audits, and handover to operations
Requirements
Essential:
  • Degree in Engineering, Life Sciences, or related technical field
  • 7+ years’ experience in CQV within pharmaceutical or life sciences manufacturing
  • Strong experience with equipment and system qualification
  • Deep understanding of GMP, validation lifecycle, and engineering quality processes
  • Fluent English
  • Ability to operate in complex, cross-functional project environments

Preferred:
  • Japanese language capability
  • Experience on large-scale CAPEX or greenfield projects
  • Exposure to automation systems and computerized system validation
Summary
This is a high-impact role on a major pharmaceutical build, offering the opportunity to lead CQV delivery on a complex, large-scale project in a highly regulated environment.
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