C&Q Execution Lead Engineer

Advanced Manufacturing Tech Solutions (AMTSOL); Singapore; Vor Ort; SGD 180.000 - 240.000; Vollzeit

Zusammenfassung

Advanced Manufacturing Tech Solutions (AMTSOL) is establishing a new ADC manufacturing facility in Tuas, Singapore, moving into field execution for commissioning, qualification, and handover. The C&Q Execution Lead Engineer will lead a team of engineers, coordinate with EPCM contractors, and ensure schedule, safety, and compliance targets are met.

You will witness pre-FAT and MC activities, lead documentation packages, and drive Set to Work and start-up phases, while upholding GDP/ALCOA+

Qualifikationen

• 10+ years of extensive C&Q experience in the systems under responsibility.
• 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 risk-based validation methodologies.
• Experience leading or coordinating C&Q engineering teams (approx. 10–15 people).
• Ability to deliver against tight project deadlines in a fast-paced construction-to-operations environment.

Aufgaben

• 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 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 and report status at daily planner meetings, escalating issues proactively.
• Execute commissioning and shakedown, including sequence of operation, control loop tuning and testing.
• Lead troubleshooting of mechanical, electrical, control-system and performance issues with evidence for SME/EPCM support.
• Field-commission utility and process systems controlled by DCS and PLCs, and support integrated commissioning testing.
• 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 update protocols.
• Execute supporting commissioning protocols and cycle development activities.
• Achieve Commissioning Completion (A2) and support Handover (H0).
• Ensure GDP and ALCOA+ compliance and safe field execution per EHS standards.
• Track and close out deficiencies, punch/snag items and changes, plan remediation actions.

Kenntnisse

CQV execution

Field leadership

C&Q planning

Risk-based validation

GMP knowledge

Team coordination

Deadline-driven

Ausbildung

Bachelor's degree in Engineering

Tools

Digital validation platforms

Jobbeschreibung

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.