Technical Project Manager – Drug Linker Facility (Pharma – Tuas)
Our Client is a Multinational Pharma and Biotech leader constructing a billion-dollar ADC manufacturing facility in Singapore.
SCOPE OF WORK
The Drug Linker Technical Project Manager (DL TPM) reports to the DL Project Manager and is responsible to lead and execute key engineering workstreams for the DrugLinker manufacturing facility scope of the Client's Project. The TPM will take the current conceptual/detailed design and drive the development of technical procurement packages, manage equipment vendor selection, and serve as the package owner throughout design, fabrication, FAT, installation, and commissioning & qualification (C&Q).
This role requires strong technical engineering knowledge, GMP facility experience, and proven project management capability within biopharmaceutical process equipment, chemical synthesis, or highcontainment manufacturing. The DL TPM will interface with the Engineering, Procurement, and Commissioning/CQV teams, to ensure that the facility meets project milestones and business objectives.
- Review and understand the current facility design, URS, process flow, and utility requirements.
- Develop comprehensive technical RFP packages including:
- Review and update of User Requirements Specifications (URS)
- Process & Instrumentation alignment (P&IDs) including PHA/HAZOP.
- Functional descriptions
- Technical evaluation criteria
- Implementation of GMP and containment requirements (e.g., OEB/OEL, closed handling, CIP/WIP)
- Implementation of ATEX requirements
- Coordinate internal SMEs (process, CQV, EHS, validation, QA) to ensure requirements are incorporated.
- Run the full RFP and vendor selection process, including:
- Bid solicitation, vendor Q&A management
- Technical and commercial bid evaluations
- Vendor capability assessments and reference checks
- Leadership of decisionmaking forums and recommendation reports
- Negotiate scope, deliverables, and timelines with selected vendors in coordination with procurement.
- Responsible for the supply, install and start-up of equipment packages (e.g., reactors, chromatography systems, highcontainment isolators, solvent systems, ancillary utilities, etc.). Supervise a team of package owners who will be the primary contacts for the major packages.
- Manage vendor progress through:
- Design reviews (DQ) and including coordination with the facility scope to ensure installation, operability, maintainability.
- Factory build oversight
- FAT preparation and execution
- Track issues, risks, and deliverables; ensure timely resolution.
- Technical issue resolution and integration: Work closely with Engineering, Procurement, and Commissioning/CQV teams to resolve technical issues rapidly, maintain package progress, and ensure prerequisites for commissioning/CQV are met (including Safe to start controls,energization readings and PSSR.)
- Quality control, inspection and turnover: Enforce AZ construction quality requirements; ensure robust ITPs (Inspection and Test Plans), inprocess inspections/testing and approval of mockups/sampls; drive accurate asbuilt documentation and CTOD (Construction Turnover Documentation); lead readiness for MC (Mechanical Completion) walkdowns, verification of records, and punchlist management to mechanical completion.
- Provide input on C&Q strategy and approach (riskbased, ASTM E2500) and IQ/OQ test plans
- Develop FAT protocols and coordinate execution with equipment vendors.
- Ensure smooth transition from vendor FAT → site receipt → installation → CQV.
- Supervise vendor SAT & subsequent testing, support CQV team in IQ/OQ execution.
- Lead a team of technical package leads to ensure the proper design, fabrication, delivery and testing of equipment within the required timeline and cost.
- Maintain detailed schedule, risks, and milestones for all assigned systems.
- Provide clear weekly reporting on progress, issues, and mitigation plans.
- Facilitate crossfunctional meetings between engineering, procurement, CQV, operations, EHS, and QA
REQUIREMENTS
- Degree in Engineering
- Experience leading team of engineers and managing equipment vendors
- Pharma Process Design or Operations background
- Experience in high containment technologies including insolators and potent compound handling
- Experience in design operations of reactor, filter dryer, isolators
- Process Safety experience
- Post-graduate engineering qualification
- Project Management experience
If you are keen to know more about this role, please email Mary at [Confidential Information] and send your resume in MS Word format. Note that only shortlisted candidates will be contacted.
