C&Q Execution Lead Engineer

A new end-to-end Antibody Drug Conjugate (ADC) manufacturing facility on a green-field site in Tuas Singapore. The project is moving into the field execution phase covering commissioning qualification and handover of process and utility systems.

The C&Q Execution Lead Engineer owns the field execution of defined C&Q scope for an allocated system or area from Mechanical Completion through commissioning qualification and handover. Reporting to the C&Q Lead the role leads a team of supporting C&Q engineers and represents the owner across scope delivered by EPCM contractors and equipment vendors ensuring schedule safety and compliance targets are met.

Key Responsibilities

• Execute the defined C&Q scope for an allocated system or area leading a team of supporting C&Q engineers and delivering against schedule safety and compliance targets.
• Deliver CQV execution in line with the project Commissioning & Qualification Execution Plan supporting plans and SOPs.
• Act as the owners representative for C&Q scope executed by third parties including EPCM contractors and equipment vendors.
• Support the C&Q Lead and regional coordinators in preparing and executing packages supplied from overseas.
• Support work package owners with C&Q planning through to FAT including witnessing pre-FAT inspections and executions.
• Own commissioning execution for allocated systems from Mechanical Completion through to Handover.
• Witness pre-Mechanical Completion (A1) installation and pre-commissioning activities (pressure testing passivation slope checks) and participate in MC walkdowns.
• Lead commissioning preparation: LOTO plans RAMS PSSR completion method statements and permit-to-work.
• Execute Set to Work (start-up and energisation) liaising with the EPCM C&Q team on utility livening-up and balancing.
• Coordinate daily execution support teams hot loop checks calibration vendors temperature mapping and sampling and report status at daily planner meetings escalating issues proactively.
• Execute commissioning and shakedown including sequence of operation (start-up run hold abort E-stop) control loop tuning pump and fan testing alarm and interlock testing and parameter tuning.
• Lead troubleshooting of mechanical electrical control-system and performance issues providing clear evidence to enable SME and EPCM support.
• Field-commission utility and process systems controlled by DCS and PLCs and support integrated commissioning testing across system interfaces.
• Coordinate vendor commissioning and SAT signing as witness on SAT protocols.
• Execute IV OV and PQ test scripts within a digital validation platform raise exceptions and support protocol updates arising from field changes.
• Execute supporting commissioning protocols and cycle development activities.
• Achieve Commissioning Completion (A2) for allocated systems and support the C&Q Lead through Handover (H0).
• Ensure GDP and ALCOA compliance throughout protocol execution and safe field execution in line with EHS standards.
• Track and close out deficiencies punch/snag list items and changes planning and executing remediation actions.

Requirements

Essential

• Bachelors degree in Engineering (Chemical Mechanical Process or related discipline) or a relevant third-level or professional qualification.
• Extensive C&Q experience in the systems under responsibility 10 years preferred.
• Proven hands-on field CQV execution experience on capital projects.
• C&Q experience across upstream and downstream systems media/buffer preparation CIP and SIP.
• Strong cGMP background and working knowledge of risk-based validation methodologies.
• Experience leading or coordinating C&Q engineering teams (approx. 1015 people across direct and matrix reporting).
• Ability to deliver against tight project deadlines in a fast-paced construction-to-operations environment.

Desirable

• PMP or equivalent project management certification.
• Experience in high-containment or potent compound (HPAPI / ADC) manufacturing facilities.
• Hands-on experience with digital validation platforms.

Key Interfaces

• Project team: Project Manager Technical Project Manager C&Q Lead Engineering Procurement Operations EHS QA and Site Facilities.
• External: EPCM / general contractors and construction managers equipment vendors design consultants and inspection agencies.