Job Description

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

• Bachelor’s 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,