Clean Utilities Engineer — GMP Systems & Operations

WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 70,000 - 120,000; Full time

Job summary

WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED is seeking a Utility Engineer responsible for the engineering, operation, and lifecycle management of Clean Utilities systems (Water for Injection, purified water, steam, process gases) to meet GMP and regulatory standards. The role spans both project commissioning and ongoing operations.

You will lead asset lifecycle activities, develop SOPs, support audits, coordinate with production, validation, quality, and external suppliers, and

Qualifications

• Degree in Mechanical, Chemical, or related engineering.
• 3–5 years in utilities engineering with 5+ years in pharma/GMP facilities.
• Experience in commissioning, qualification, and lifecycle management of CU systems.
• Deep knowledge of CU systems: PW, WFI, steam, gases, CIP/SIP.
• Familiarity with GMP/cGMP and regulatory standards.
• Project and vendor management with equipment package ownership.
• Strong analytical and problem-solving skills with risk assessments (FMEA, HAZOP).
• Effective cross-functional collaboration and audit support.
• Willingness to travel short-term if required.

Responsibilities

• Provide technical guidance in installation and validation of CU systems.
• Own equipment procurement lifecycle from specification to installation.
• Support commissioning, qualification, and acceptance with required documentation.
• Collaborate with production, validation, and quality for seamless execution.
• Engage with global design teams, suppliers, and stakeholders for alignment.
• Review CU engineering documents and rectify GMP/non-conformities.
• Support risk assessments (FMEA, HAZOP) to mitigate issues.
• Oversee daily operations, maintenance, and verification of CU systems.
• Develop SOPs, operation manuals, and train site operators.
• Participate in audits and ensure cGMP compliance.
• Drive continuous improvement for efficiency, safety, and sustainability.

Skills

Utilities engineering

GMP compliance

Vendor management

Project management

Risk assessments

Education

Diploma / Bachelor's degree in Mechanical, Chemical, or related Engineering discipline

Job description

WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED is seeking a Utility Engineer responsible for the engineering, operation, and lifecycle management of Clean Utilities systems (Water for Injection, purified water, steam, process gases) to meet GMP and regulatory standards. The role spans both project commissioning and ongoing operations.

You will lead asset lifecycle activities, develop SOPs, support audits, coordinate with production, validation, quality, and external suppliers, and