Equipment Package Lead (pharmaceutical)
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About the role
About our client : Our client is a global biopharmaceutical organization focused on developing and manufacturing innovative medicines About the role : The Equipment Package Lead will be responsible for end-to-end technical ownership of assigned process equipment packages for a pharmaceutical manufacturing facility. This includes leading technical procurement, vendor management, design coordination, and execution through installation, commissioning, and qualification phases. Lead technical development of equipment packages, including User Requirement Specifications (URS), P&IDs, functional specifications, and RFP documentation. Ensure alignment with GMP, safety (OEB/OEL), containment, CIP/WIP, and ATEX requirements. Coordinate cross-functional inputs from engineering, CQV, EHS, QA, and process teams to ensure complete and compliant technical specifications. Manage end-to-end vendor selection process, including RFQ issuance, technical/commercial bid evaluations, vendor clarifications, and recommendation reports. Serve as primary technical owner for assigned equipment packages (e.g., thermal oxidizers, scrubber systems, solvent storage and transfer systems, and associated utilities). Oversee vendor design execution, fabrication progress, and interface coordination with site construction teams. Develop and execute Factory Acceptance Testing (FAT) protocols and manage vendor FAT activities. Ensure readiness for installation, commissioning, and qualification, including Pre-Startup Safety Review (PSSR), Mechanical Completion, and turnover documentation. Support CQV activities, including IQ/OQ execution, validation planning, and risk-based commissioning strategies (ASTM E2500 aligned). Enforce construction quality standards through inspection and test plans (ITPs), punch list management, and as-built documentation control. Maintain project schedules, risk registers, and provide regular progress updates to the Technical Project Manager. Participate in cross-functional project meetings to ensure alignment across engineering, procurement, CQV, operations, EHS, and QA teams. About you: Bachelor's degree in Chemical, Mechanical, Process, or related engineering discipline. Minimum 5 years of experience in pharmaceutical or GMP-regulated manufacturing projects with direct equipment package ownership. Strong experience in equipment lifecycle management including design, procurement, FAT/SAT, installation, commissioning, and qualification. Technical knowledge of process equipment such as thermal oxidizers, scrubbers, solvent storage and transfer systems, and related utility systems. Experience working in GMP environments with knowledge of FDA, EMA, or PIC/S regulatory requirements. Familiarity with high-containment or potent compound manufacturing environments is highly preferred. Understanding of ATEX, process safety, hazardous chemical handling, and pharmaceutical engineering standards. Proven ability to manage vendors, review technical documentation, and resolve engineering issues during execution phases. Strong communication and stakeholder management skills across engineering, CQV, EHS, QA, and operations teams. Willingness to travel internationally to vendor sites (e.g., China, Europe). Other: Work location: Tuas Work hours: 5 days Job Type: Project-based contract *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
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