CQV Manager - Pharmaceutical Manufacturing

About the role

Turner & Townsend is recruiting a Commissioning, Qualification and Verification (CQV) Manager for a pharmaceutical manufacturing project in Singapore. The role leads commissioning strategies, qualification and validation plans, and builds and leads a CQV team, working with engineering, construction, quality and operations teams.

Key responsibilities

• Develop commissioning strategies, commissioning master plans and qualification/validation strategies including the Validation Master Plan (VMP)
• Lead CQV planning and execution across process, utility, facility and automation systems, and give technical guidance to stakeholders
• Prepare commissioning plans, qualification and verification protocols and documentation, and establish system boundaries and interdependency matrices
• Take part in FATs, SATs, system walkdowns and turnover activities, and approve system turnover packages
• Coordinate system handovers between construction and commissioning teams and support operational readiness and handover to manufacturing operations
• Build and lead a CQV team, coach and mentor personnel, and manage external contractors and service providers
• Support project scheduling, resource planning, cost estimation, and monitor progress, performance metrics and KPIs
• Incorporate EHS&S requirements into CQV activities and support procurement and contracting of equipment, skids and modular systems
• Partner with site operations on operator training and facility startup, qualification completion and production readiness

Required profile

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Life Sciences or a related technical discipline
• At least 15 years of CQV experience on large-scale pharmaceutical, biopharmaceutical or life sciences capital projects
• Proven experience leading CQV execution on major greenfield pharmaceutical manufacturing projects and as part of a senior project leadership team
• Experience managing commissioning, qualification and startup for GMP-regulated facilities
• Experience on large pharmaceutical capital projects in Singapore is highly desirable
• Willingness to travel internationally and to relocate to Singapore for the duration of the assignment
• Experience supporting facility startup and operational handover in a regulated environment is highly preferred

Required skills

• Strong knowledge of GMP requirements and standards including FDA, EMA, ISPE, ASTM and GAMP guidance
• Extensive experience with process equipment, clean utilities, facilities, automation systems and manufacturing operations
• Understanding of the validation lifecycle and CQV best practices
• Leadership, project management, planning and execution, and strong communication and collaboration skills