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About our client: Our client is a leading global pharmaceutical company.
About the role:
1. Technical Package Development
. 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.
2. Vendor Selection & Procurement
. 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 decision making forums and recommendation reports
. Negotiate scope, deliverables, and timelines with selected vendors in coordination with procurement.
3. Package Ownership
. Responsible for the supply, install and start-up of equipment packages (e.g., reactors, chromatography systems, high containment 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.
4. FAT, Commissioning & Qualification
. 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 readiness and PSSR).
. Quality control, inspection, and turnover: Enforce the construction quality requirements ensure robust ITPs (Inspection and Test Plans), in process inspections/testing, and approval of mock ups/samples drive accurate as built 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 (risk based, 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.
5. Project Leadership & Governance
. 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 cross functional meetings between engineering, procurement, CQV, operations, EHS, and QA.
About you:
. 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.
Other:
.Please note that only shortlisted candidates will be contacted..
Employment Agency: Kingsforce Management Services Pte. Ltd.
Employment Agency Licence No: 94C3545
EA Personnel: Kimberly Wong
EA Personnel Reg. No.: R1984508
Job ID: 145450335