Utilities Engineer – GMP Biopharma Ops & CAPA

Coalesce Management Consulting

Singapore

On-site

SGD 70,000 - 110,000

Full time

23 hours ago
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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

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.

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