Clean Utility Engineer

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

Job Summary

The Utility Engineer is responsible for the engineering, operation, and lifecycle management of Clean Utilities (CU) systems, including purified water, water for injection, pure steam, process gases, and other utility systems. The role encompasses both the project phase and operational phase, ensuring systems are designed, installed, validated, and maintained to meet GMP and regulatory requirements while delivering safe, reliable, and efficient performance. The role holder will collaborate with internal stakeholders, suppliers, and contractors to drive technical excellence and project success.

Responsibilities

Project Phase (Commissioning, Qualification)

• Provide technical expertise and guidance in the installation, and validation of clean utilities systems (e.g., purified water, WFI, pure steam, special gases), ensuring optimal performance, reliability, and compliance with GMP and industry standards.
• Act as package owner for equipment procurement, managing the full lifecycle from specification, vendor selection, and purchasing to installation, commissioning, and qualification.
• Support system commissioning, qualification, and final acceptance, ensuring suppliers deliver required documentation and materials, and confirming the system meets functional, compliance, and safety requirements before handover.
• Collaborate with cross-functional teams, including production, validation, and quality, to ensure seamless project execution and smooth handover to operations.
• Develop and maintain strong working relationships with the global design team, suppliers, and key stakeholders to ensure alignment of project objectives and effective communication.
• Review and provide technical input on CU engineering design documents, specifications, and construction quality, ensuring rectification of deficiencies to meet GMP and site standards.
• Support project risk assessments (e.g., FMEA, HAZOP) to identify and mitigate potential system issues.

Operational Phase (Operation, Maintenance, Continuous Improvement)

• Oversee daily operations, monitoring, maintenance, and verification of CU systems to ensure effective, reliable, and compliant performance.
• Develop and maintain SOPs, operation manuals, and training materials; conduct training for site operators and ensure proper execution of operational practices.
• Implement and monitor preventive maintenance programs to minimize downtime, ensure reliability, and extend equipment lifespan.
• Collaborate with Quality to prepare documents, investigate deviations, support change control, and ensure compliance with regulatory expectations.
• Provide technical support during internal, client, and external audits, representing CU/BU systems as SME.
• Ensure all activities comply with cGMP, company quality standards, and EHS policies.
• Offer technical guidance, review drawings, and support renovation and upgrade projects, ensuring proper system acceptance and compliance.
• Continuously evaluate and improve operational processes, leveraging industry best practices and new technologies to enhance efficiency, sustainability, and system performance.
• Complete other tasks as assigned by supervisors or management.

Requirements

• Diploma / Bachelor's degree in Mechanical, Chemical, or related Engineering discipline.
• Minimum 3-5 years of relevant work experience in utilities engineering, with at least 5 years in pharmaceutical, biopharmaceutical, or other GMP-regulated facilities.
• Experience in commissioning, qualification, and lifecycle management of CU systems is strongly preferred.
• Deep technical knowledge of CU systems (purified water, WFI, pure steam, compressed air, steam, chilled water, Clean-In-Place (CIP) / Sterilize-In-Place (SIP) Stations etc.).
• Strong familiarity with GMP, cGMP, and regulatory standards applicable to utilities.
• Skilled in project and vendor management, with experience in equipment package ownership.
• Strong analytical and problem-solving skills, with experience in risk assessments (FMEA, HAZOP).
• Effective communication skills, with the ability to represent CU systems during audits and inspections. Strong communication and interpersonal skills, with the ability to collaborate across cross-functional teams.
• Detail-oriented and capable of managing multiple tasks and priorities.
• Team-oriented mindset with a focus on compliance, safety, and operational excellence.
• Willingness to support both project and operational activities, including short-term travel if required.