Commissioning, Qualification, and Validation (CQV) Manager (Pharma – Tuas)
Our Client is a Multinational Pharma and Biotech leader constructing a billion-dollar ADC manufacturing facility in Singapore.
The Commissioning, Qualification, and Validation (CQV) Manager reports to the Project Director (PD) and is a key member of the SGOP project team. The CQV Manager leads the planning and execution of commissioning, qualification, and validation for manufacturing buildings (DS, DL, DP), supporting utilities, and warehousing/packaging interfaces, in collaboration with PMs, Design and Technical Managers, Subject Matter Experts (SMEs), Work Package Owners (WPOs), contractors/OEMs, operations and quality. The role ensures safe, compliant, and efficient CQV delivery in accordance with the approved Validation Master Plan (VMP) and CQV Strategy, aligned to AZ standards and regulatory expectations (GMP/GDP).
Scope of Work Quality culture and governance: Champion a “Right First Time” culture across CQV activities; ensure CQV execution aligns with the VMP, CQV Strategy, and Client’s governance, with clear acceptance criteria and approval pathways.Strategy and planning: Building on the System Impact Assessment (SIA) and CQV Strategy from Concept Design, develop and maintain the CQV Execution Plan during entire project lifecycle, including resource plans, logical sequencing, and dependencies across building services, process systems, and utilities.VMP ownership: Ensure the Project VMP is generated (as required), established, approved, maintained, and communicated for use; cascade requirements to WPOs, contractors, and vendors.Risk-based CQV: Lead System Risk Assessments and CQV planning assessments (risk assessments, supplier assessments, RFP deliverable reviews) to enable risk-based testing, opportunities for acceleration, and scope optimization per stage roadmap.Construction-to-CQ transition: Coordinate closely with the Construction Manager to manage the transition from Mechanical Completion (MC) to Commissioning Completion, including CTOD (Construction Turnover Documentation) and VTOP (Vendor Turnover Documentation) acceptance, punchlist closure strategy, and “Safe to Start” (including LOTO) reviews prior to energization.Permitting and SHE during start-up: Implement Client’ s Global Engineering Client SHE Requirements with the Construction SHE Manager and Engineering SHE Lead, focusing on start-up risks, energization readiness, and simultaneous operations during CQV.Documentation and protocol oversight: Oversee preparation, execution, and approval of CQV documentation (test protocols/scripts, reports, raw data and calculations), ensuring results meet defined acceptance criteria and Client’s standards, processes, and procedures; maintain data integrity and audit readiness.FAT/SAT and OEM coordination: Provide oversight of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) and their documentation; coordinate OEM engagement and approvals in line with Client’s governance; align with equipment-specific qualification requirements.Live systems stewardship: Manage “live system” operations while under project care and custody during CQV, including status controls and boards, escalation processes, and interface with operations for temporary use or phased turnover.Stakeholder engagement: Support the PM in managing Client’ s customer stakeholders (e.g., Site Quality for GMP compliance and Receiving Client team for operational readiness); enable effective use of GVLMS (global validation/lifecycle management system) by client/end-users (e.g., entity creation and approvals).Schedule control and reporting: Develop, integrate, and maintain the CQV schedule with Project Controls; manage dependencies across DS/DL/DP systems, spine interfaces, CUB, Substation, and supporting utilities; report CQV progress, risks, and mitigations to the PD and stakeholders.
Resource and capability management: Lead and manage CQV/CSV resources (personnel, documentation tools, test equipment); ensure appropriate training and competency are in place and maintained for safe and effective execution.Interface management: Maintain an interface register for CQV dependencies across manufacturing buildings, utilities, spine, and warehouses; coordinate sequencing to avoid conflicts and protect milestones.Exception and punchlist closure: Lead snag/exception management and closeout during CQV; ensure timely resolution and documentation updates to achieve qualification and readiness targets.Handover and approvals: Plan and manage system handover post successful commissioning and/or qualification to Client Representatives; support acceptance of handover certificates, and provide Go/No-Go checkpoints for CQV stage progression; support PD to obtain handover sign-off with the Client Representative team.Continuous improvement: Identify, capture, and share best practices and lessons learned from internal/external projects; drive improvements in CQV efficiency, safety and compliance.
REQUIREMENTS
Degree in Engineering, Construction Management, and/or project cost control.Proven leadership experience in a project construction environment.Comprehensive knowledge of relevant Safety, Health, and Environment legislation.Strong capability to manage cross-building interfaces.Expertise in constructability and cleanroom/Good Manufacturing Practice execution.
If you are keen to know more about this role, please email Mary at marymarquez@rmagroup.com.sg and send your resume in MS Word format. Note that only shortlisted candidates will be contacted.
Mary Marquez (EA Regn No: R1326974)RMA Consultants Pte Ltd (EA Licence No: 93C4403)