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.

Qualifications :

Education

• Bachelors 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 decision-making ability.

Additional Requirements

• Willingness to travel internationally as required for project execution supplier visits FATs and startup activities.
• Ability to relocate to Singapore for the duration of the project assignment.
• Experience supporting facility startup and operational handover in a regulated manufacturing environment is highly preferred.

Additional Information :

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Remote Work :

No

Employment Type :

Full-time