Equipment Package Lead (pharmaceutical)

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