C&Q Project Manager
Varalakshmi ChagantiUnited StatesMIDPosted 7d ago
PharmaceuticalBiotechC&Q/CQVProject managementGMP qualification documentationProcess equipmentClean utilitiesHVACGMP-critical systems
About the Role
We are seeking a C&Q Project Manager to lead Commissioning & Qualification project activities in the pharmaceutical and biotech industry. This role involves managing the qualification of manufacturing equipment, facilities, utilities, and process systems while ensuring compliance with regulations.
Key Responsibilities
• Lead Commissioning & Qualification (C&Q/CQV) project activities
• Manage qualification of pharmaceutical manufacturing equipment, facilities, utilities, and process systems
• Review and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation
• Coordinate with Engineering, Validation, QA, Automation, and Manufacturing teams
• Ensure compliance with cGMP, FDA regulations, ASTM E2500, and ISPE guidelines
• Manage project schedules, resources, risks, vendors, and project deliverables
• Support deviation management, change control, CAPA, and audit readiness
Requirements
• Pharmaceutical or Biotech C&Q/CQV experience
• Project management or team leadership experience
• Strong knowledge of GMP qualification documentation
• Experience with process equipment, clean utilities, HVAC, or GMP-critical systems
• Excellent communication and documentation skills