Project Manager Senior CQV Pharmaceutical

Introduction
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.

• 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.

• 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.

• Minimum 8-12 years of experience in pharmaceutical biotech or life sciences industries.
• Minimum 5 years of direct CQV project management experience within GMP-regulated manufacturing environments.
• Proven experience managing large-scale capital projects facility expansions or greenfield startup projects.
• Strong experience with commissioning and qualification of:
  • Cleanrooms
  • Process equipment
  • Utilities
  • Automation systems
  • Manufacturing processes
• Experience authoring and reviewing validation lifecycle documentation.
• Demonstrated success leading cross-functional teams and managing multiple project workstreams simultaneously.
• Experience supporting FDA audits and regulatory inspections.
• Background in biologics sterile fill-finish vaccine API or aseptic manufacturing environments strongly preferred.

• Bachelors degree in Engineering Life Sciences Pharmaceutical Sciences or related technical discipline.
• Strong understanding of:
  • cGMP regulations
  • FDA validation requirements
  • ISPE Baseline Guides (inc. C&Q) and ASTM E2500 GUIDE
  • GAMP 5 principles
• Proficiency with project management methodologies scheduling tools and reporting systems.
• Excellent communication leadership and stakeholder management skills.
• Ability to work effectively in fast-paced highly regulated project environments.

• Digital Validation software experience (i.e. Kneat or equivalent)
• PMP certification preferred.
• Experience with DeltaV MES SCADA or other pharmaceutical automation platforms.
• Familiarity with Kneat TrackWise Veeva or electronic validation systems.
• Previous consulting or EPCM experience is a plus.
• Lean Six Sigma certification preferred.