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CQV Manager
Job Description
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
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
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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