CQV Manager - Pharmaceutical Manufacturing

Project Leadership & Strategy • Develop and implement commissioning strategies and commissioning master plans for project execution. • Develop qualification and validation strategies, including the Validation Master Plan (VMP). • Lead CQV planning and execution activities across process, utility, facility, and automation systems. • Provide CQV leadership and technical guidance to project stakeholders throughout the project lifecycle. Commissioning & Qualification Execution • Develop commissioning plans for all systems. • Prepare and review qualification and verification protocols and associated documentation. • Establish system boundaries and interdependency matrices to support efficient project execution. • Participate in Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), system walkdowns, and turnover activities. • Review and approve system turnover packages from construction. • Support field execution of commissioning, qualification, and verification activities. Cross-Functional Collaboration • Collaborate closely with Engineering, Process, Automation, Construction, Quality, and Operations teams to ensure coordinated project delivery. • Coordinate system handover sequences between construction and commissioning teams. • Work with Quality teams to ensure compliance with applicable quality and regulatory standards. • Support operational readiness activities and ensure smooth handover to manufacturing operations. Team Management • Build and lead a CQV team responsible for planning, protocol development, testing, and field execution. • Provide coaching, mentoring, and technical guidance to CQV personnel. • Manage external contractors and service providers supporting CQV execution where applicable. Project Controls & Compliance • Support project scheduling, resource planning, and cost estimation activities. • Implement systems to monitor CQV progress, performance metrics, and project KPIs. • Ensure Environmental, Health, Safety and Sustainability (EHS&S) requirements are incorporated into all CQV activities. • Support procurement and contracting strategies related to equipment, skids, modular systems, and off-site fabrication. Startup & Operational Readiness • Partner with site operations teams to support operator training and readiness programs. • Facilitate efficient handover of systems to operations. • Support facility startup, qualification completion, and production readiness activities. Education • Bachelor's Degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical discipline. Experience • Minimum 15 years of CQV experience supporting large-scale pharmaceutical, biopharmaceutical, or life sciences capital projects. • Proven experience leading CQV execution on major greenfield pharmaceutical manufacturing projects. • Demonstrated experience serving as part of a senior project leadership team. • Strong experience managing commissioning, qualification, and startup activities for GMP-regulated facilities. • Experience working on large pharmaceutical capital projects in Singapore is highly desirable. Technical Expertise • Strong knowledge of GMP requirements and industry standards including FDA, EMA, ISPE, ASTM, and GAMP guidance. • Extensive experience with process equipment, clean utilities, facilities, automation systems, and manufacturing operations. • Strong understanding of validation lifecycle management and CQV best practices. Skills & Competencies • Outstanding leadership and stakeholder management capabilities. • Strong project management, planning, and execution skills. • Excellent communication and collaboration skills. • Proven ability to lead multidisciplinary teams in complex project environments. • Strong problem-solving and deci