Project Manager - Senior CQV Pharmaceutical

Senior CQV Project Manager

Visium Resources has been asked to identify qualified candidates for a full time position as a Senior CQV Project Manager located in Raleigh, NC. We are seeking an experienced Senior CQV Project Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. This individual will oversee cross-functional CQV execution for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes while ensuring compliance with FDA, cGMP, and global regulatory standards.

The ideal candidate will possess strong pharmaceutical project leadership experience within biotech, sterile manufacturing, fill-finish, API, or biologics environments and will serve as a key liaison between engineering, quality, validation, manufacturing, and external vendors. This role requires the ability to manage project schedules, budgets, risks, resources, and validation deliverables in support of facility expansions, new product introductions, and operational readiness initiatives.

Key Success Criteria

• Experience leading major expansion C&Q projects start to finish (brownfield or greenfield). From strategy / planning through to full doc prep & execution
• Writes CQV Strategies & Plans.
• CQV Schedule
• Should have experience with C&Q of process equipment.
• Has experienced with integrated CQV (ASTM E2500 and ISPE C&Q baseline guide)
• Has experience with digital validation (i.e. Kneat or other software) is a major asset but not required.
• Capital Improvements experience is a major asset but not required.

Key Responsibilities

• Lead all CQV project activities for pharmaceutical and biotech manufacturing projects.
• Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.
• Coordinate commissioning and qualification activities for:
  • Process equipment
  • Clean utilities
  • HVAC systems
  • Automation and control systems
  • Manufacturing and packaging lines
• Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards.
• Oversee execution of:
  • FAT/SAT protocols
  • IQ/OQ/PQ protocols
  • Validation documentation
  • Deviations and CAPAs
  • Change controls
• Collaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support project milestones and inspection readiness.
• Manage third-party CQV consultants, contractors, and vendors.
• Provide risk assessments and mitigation strategies to maintain project timelines and compliance objectives.
• Support startup, operational readiness, and technology transfer activities.
• Present project status updates and KPI reporting to senior leadership and stakeholders.