C&Q Execution Lead Engineer

Advanced Manufacturing Tech Solutions

Singapore

On-site

SGD 180,000 - 240,000

Full time

38 hours ago
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Job summary

Advanced Manufacturing Tech Solutions in Singapore seeks a C&Q Execution Lead Engineer to manage field CQV activities for a new ADC manufacturing facility. You will lead a team of engineers from MC through Handover, ensuring compliance, safety, and timely delivery of commissioning and qualification tasks.

The role requires 10+ years of CQV delivery on capital projects, strong GMP background, and ability to coordinate with EPCM contractors and vendors in a fast-paced construction-to-operations

Qualifications

  • Bachelor’s degree in Engineering or related discipline.
  • 10+ years of C&Q experience on capital projects.
  • Hands-on field CQV execution on projects.
  • Experience with upstream and downstream systems, CIP and SIP.
  • Strong cGMP background with risk-based validation.

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.
  • Lead CQV execution in line with the project Commissioning & Qualification Execution Plan, supporting plans and SOPs.
  • Act as the owner’s 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 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, 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.

Skills

CQV field execution
C&Q leadership
GMP / GDP knowledge
Risk-based validation
Cross-functional coordination
PMP (Desirable)

Education

Bachelor’s degree in Engineering

Job description

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 owner’s 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
  • Bachelor’s 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. 10–15 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.
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