Utilities Engineer – GMP Biopharma Ops & CAPA

Coalesce Management Consulting; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Coalesce Management Consulting seeks a Utilities Engineer to support manufacturing operations in a leading biopharmaceutical facility in Singapore. You will manage critical utility systems and ensure compliant, reliable processes.

You will lead change controls, qualification activities (FAT/SAT/IQ/OQ/PQ), review documentation, and collaborate with engineering, maintenance, validation, quality and production teams to drive continuous improvement and minimize downtime.

Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or Process Engineering.
• Experience in change deviation management preferred.
• Strong vendor management, process/manufacturing, and equipment lifecycle management experience.
• Good organizational, problem-solving, and communication skills.

Responsibilities

• Support operation, maintenance, and lifecycle management of critical utility systems (RO, WFI, Clean Steam, PW, Compressed Air).
• Lead and manage change control activities for installation, upgrade, modification, and commissioning of utility systems/equipment.
• Ensure all utility activities comply with GMP, safety, and regulatory requirements.
• Perform root cause analysis and implement corrective and preventive actions (CAPA).
• Troubleshoot equipment failures, utility disruptions, and performance issues to minimise downtime.
• Coordinate with engineering, maintenance, validation, quality and production teams to execute utility projects and system improvements.
• Support qualification and commissioning activities (FAT, SAT, IQ, OQ, PQ) for new/modified utility equipment.
• Review and update engineering documentation (SOPs, maintenance procedures, risk assessments, technical reports).
• Monitor system performance, reliability, and trends; identify opportunities for optimisation and continuous improvement.
• Manage contractors and vendors involved in utility maintenance and project activities.

Education

Bachelor's degree in Chemical Engineering, Mechanical Engineering, or Process Engineering

Job description

We are seeking a Utilities Engineer to support manufacturing operations within a leading biopharmaceutical facility. The successful candidate will work closely with cross-functional teams to ensure reliable, compliant, and efficient manufacturing processes for assigned utility systems, and effective management of routine engineering activities.

Key Responsibilities:

• Support the operation, maintenance, and lifecycle management of critical utility systems including Reverse Osmosis (RO), Water for Injection (WFI), Clean Steam, Purified Water, Compressed Air, and associated utility equipment.
• Lead and manage change control activities for the installation, upgrade, modification, and commissioning of utility systems and equipment.
• Ensure all utility-related activities are executed in compliance with GMP, safety, and regulatory requirements.
• Perform root cause analysis and implement effective corrective and preventive actions (CAPA) to prevent recurrence.
• Conduct in-depth troubleshooting of equipment failures, utility disruptions, and performance issues to minimise downtime and production impact.
• Coordinate with engineering, maintenance, validation, quality, and production teams to ensure successful execution of utility projects and system improvements.
• Support qualification and commissioning activities including FAT, SAT, IQ, OQ, and PQ for new or modified utility equipment.
• Review and update engineering documentation including SOPs, maintenance procedures, risk assessments, and technical reports.
• Monitor system performance, reliability, and operational trends while identifying opportunities for optimisation and continuous improvement.
• Manage contractors and vendors involved in utility maintenance and project activities.

Preferred Experience

• Bachelor's Degree in Chemical Engineering, Mechanical Engineering, Process Engineering, or a related engineering discipline.
• Experience in change deviation management is preferred.
• Strong vendor management, process and manufacturing, and equipment lifecycle management experience.
• Good organizational, problem-solving, and communication skills.