CQV Lead Manager

We are seeking a CQV Lead / Manager to lead Commissioning Qualification and Validation activities for a biopharmaceutical facility expansion project. The role will focus on end-to-end CQV delivery across new manufacturing areas clean zones laboratory expansions and associated facilities utilities automation and digital systems.

The position will ensure successful execution of CQV lifecycle activities from design through to final handover aligned with GMP requirements project timelines and integrated qualification strategies.

Key Responsibilities

• Lead and manage end-to-end CQV activities from URS DQ FAT/SAT through IQ OQ PQ and final system handover
• Define and implement lean integrated qualification strategies to optimize project delivery
• Manage and mentor the CQV team ensuring alignment with project timelines and deliverables
• Coordinate with cross-functional teams including construction facilities & utilities process automation operations QC QA and EHS
• Interface with EPCM contractors package vendors and system suppliers to ensure compliant CQV execution
• Establish and drive project controls including planning scheduling progress tracking and reporting
• Lead regular coordination meetings and provide clear updates to project stakeholders
• Manage change control deviations and documentation throughout the CQV lifecycle
• Ensure compliance with cGMP GAMP 5 and regulatory requirements
• Support development review and approval of validation protocols and reports
• Drive audit readiness and ensure systems meet user requirements timelines and budget expectations

Required Qualifications & Experience

• Bachelors degree in Engineering (Chemical Mechanical Biotechnology or related discipline)
• 10 years of experience in CQV / Validation within pharmaceutical or biopharmaceutical manufacturing
• Proven experience leading CQV activities for capital projects or facility expansions
• Strong hands-on experience across full validation lifecycle (URS to PQ and handover)
• Good understanding of cGMP GAMP 5 21 CFR Part 11 and data integrity requirements
• Experience with process equipment cleanrooms and facilities & utilities systems (HVAC WFI clean steam etc.)
• Exposure to automation and digital systems (DeltaV / PLC / MES) is preferred
• Strong leadership stakeholder management