ENG Bauen · 1 week ago
CQV Manager
North Carolina, United States
Contract
Onsite
Senior Level, Lead/Staff
10+ years expENG Bauen is supporting a global pharmaceutical client in the appointment of an experienced CQV Manager to join their North American project execution organization. This role will play a critical part in the delivery of multiple concurrent CAPEX projects within a highly regulated GMP environment, ensuring assets are delivered safely and compliantly.
Staffing & Recruiting
Hiring Manager
Zaid Elgahmi
Responsibilities
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
Drive risk-based qualification approaches (ASTM E2500 / ICH Q9) to optimize delivery timelines
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
Qualification
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
Company
ENG Bauen
ENG Bauen is an international talent management and advisory consultancy that provides corporate-level project development and execution expertise and technical engineering resources to support mission-critical projects in the Global Energy sector.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase