Senior CU / BU Engineer

Job Summary

The CU/BU Engineer is responsible for the engineering, operation, and lifecycle management of Clean Utilities (CU) and Black Utilities (BU) 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.

Job content

Project Phase (Design, Commissioning, Qualification)

1. Provide technical expertise and guidance in the design, 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.
2. Provide technical expertise and guidance in the design and installation of black utilities systems (e.g., compressed air, boilers, cooling towers, chilled water, etc.).
3. Act as package owner for equipment procurement, managing the full lifecycle from specification, vendor selection, and purchasing to installation, commissioning, and qualification.
4. 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.
5. Collaborate with cross-functional teams, including production, validation, and quality, to ensure seamless project execution and smooth handover to operations.
6. Develop and maintain strong working relationships with the global design team, suppliers, and key stakeholders to ensure alignment of project objectives and effective communication.
7. Review and provide technical input on CU/BU engineering design documents, specifications, and construction quality, ensuring rectification of deficiencies to meet GMP and site standards.
8. Support project risk assessments (e.g., FMEA, HAZOP) to identify and mitigate potential system issues.

Operational Phase (Operation, Maintenance, Continuous Improvement)

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

Requirements

1. Bachelor's degree or above in Mechanical, Chemical, or related Engineering discipline.
2. Minimum 8 years of relevant work experience in utilities engineering, with at least 5 years in pharmaceutical, biopharmaceutical, or other GMP-regulated facilities.
3. Experience in commissioning, qualification, and lifecycle management of CU/BU systems is strongly preferred.
4. Deep technical knowledge of CU and BU systems (purified water, WFI, pure steam, compressed air, steam, chilled water, etc.).
5. Strong familiarity with GMP, cGMP, and regulatory standards applicable to utilities.
6. Skilled in project and vendor management, with experience in equipment package ownership.
7. Proficient in engineering tools such as AutoCAD and utilities monitoring systems.
8. Strong analytical and problem-solving skills, with experience in risk assessments (FMEA, HAZOP).
9. Effective communication skills, with the ability to represent CU/BU systems during audits and inspections.Strong communication and interpersonal skills, with the ability to collaborate across cross-functional teams.
10. Detail-oriented and capable of managing multiple tasks and priorities.
11. Team-oriented mindset with a focus on compliance, safety, and operational excellence.
12. Willingness to support both project and operational activities, including short-term travel if required.
13. Is able to go for minimum 3 months training in China.
14. Proficiency in the Chinese language is an advantage.