CQV Manager

CQV Manager | Major Pharmaceutical Capital Programs

ENG Bauen is supporting a global pharmaceutical client in the appointment of an experienced CQV Manager to join their North American project execution organisation, supporting a large suite of high-value pharmaceutical capital projects across the US Research Triangle.

This role will play a critical part in the delivery of multiple concurrent CAPEX projects, including greenfield facilities, brownfield expansions, process upgrades, technology transfers, and site-wide remediation programs within a highly regulated GMP environment.

As CQV Manager, you will hold end-to-end responsibility for Commissioning, Qualification, and Validation strategy and execution, ensuring assets are delivered safely, compliantly, and in a state of operational readiness. You will work closely with Engineering, Construction, Automation, Quality, and Operations teams to ensure seamless transition from project delivery into routine manufacturing.

This is a senior, client-facing position requiring strong leadership, technical depth, and the ability to operate across complex multi-project portfolios.

• Lead and manage CQV execution across a diverse portfolio of pharmaceutical capital projects.
• Develop and implement CQV strategies, plans, and schedules aligned with overall project and regulatory requirements.
• Ensure compliance with FDA, EMA, and global GMP regulations, including data integrity and quality standards.
• Oversee and coordinate CQV contractors and system owners, ensuring consistent execution across sites.
• Partner with Engineering, Automation, Quality, and Operations to support operational readiness and handover.
• Provide clear reporting on CQV progress, risks, and milestones to senior stakeholders.
• Support inspections, audits, and regulatory interactions as required.

• 10–15+ years’ experience in Commissioning, Qualification, and Validation within the pharmaceutical, biotech, or life sciences sectors.
• Proven experience supporting large CAPEX programs across greenfield and brownfield GMP facilities.
• Strong knowledge of FDA, EMA, cGMP, Annex 1, and data integrity requirements.
• Experience managing multi-discipline CQV teams (Facilities, Utilities, Process, Automation).
• Demonstrated ability to lead CQV delivery from design through to handover and licensure.
• Excellent stakeholder management and communication skills.
• Willingness to travel across the US Research Triangle project sites as required.

• Influence delivery of a world-class pharmaceutical capital program
• High visibility, senior role within a strategic, long-term project portfolio
• Opportunity to shape CQV strategy, standards, and best practices across multiple sites
• Partner with a global client committed to quality, compliance, and operational excellence

CQV Manager, Commissioning, Qualification, Validation, GMP, FDA, EMA, Life Sciences, Pharmaceutical, Biotech, Biotechnology, CAPEX, Greenfield, Brownfield, Operational Readiness, Automation, Utilities, Process Systems, CQV Lead, Quality, Compliance, US Research Triangle