Clean Utility Engineer

KEY ACCOUNTABILITIES:

1. Summary: The clean utility engineer is responsible for design review, equipment or system specification review or preparation, installation, testing and commissioning of clean utility equipment & system (PW, WFI, PS, CA, CO2, O2, LN2 etc.,) together with project team during the construction phase. And then after takeover, you are required to manage maintenance and renovation works in the fields of clean utility system on site, with the necessary guidance and direction from XSEM department, to achieve site and company goals.

Project Construction Phase:

• Review, check and approve deliverables of clean utility system produced by project team or contractors.
• Support and participate in installation, testing and commissioning activities of CU systems, working closely with internal stakeholders, vendors, and contractors to ensure systems are installed correctly and function as intended.
• Review technical drawings, specifications, URS and related document for equipment and systems, including generation & distribution of PW & WFI, PS, CA etc.,
• Support to prepare the C&Q related documents like URS, DR, FCCA, SIA etc.,
• Participate in system startup, shake down, pre startup check and commissioning of the engineering and process systems.
• Develop technical specifications and scopes of work for project team, engineering firms and contractors.
• Liaise with other business units, sub-contractors and suppliers as appropriate in order to backing the project.
• Collaborate with project team to set-up training documents for maintenance personnel.
• As end users, work with stakeholders to ensure a smooth handover of clean utilities system.

Operational Phase:

• Perform daily operation and maintenance activities of clean utility system.
• Implement and improve preventive maintenance programs by reviewing operations, quality control and maintenance reports and statistics with operational standards/cGMP for plant clean utilities system.
• Support or lead in commissioning & qualification of related system in an operating plant, including related HAZOP, HAZID, FMEA, CMMS, SOPs and regulation requirements.
• Actively seek improvements to systems and processes through continuous improvement, streamlining and simplification.
• To be able to assess and manage spare parts for clean utility equipment and systems.
• Review and update the operation support documents like SOP, PM plan, Training matrix etc.,
• Ensuring assigned CAPA/deviation/CCR/DCR tasks are managed and resolved in a timely manner.
• Perform work within budget and schedule parameters and provide appropriate feedback to manager for workload, schedule and cost management.
• Supervise and work in the field assisting on shut-down, startups, maintenance, modification & improvement projects.
• Troubleshoot critical or major plant issues, participate in Root Cause Analysis studies, plant improvement initiatives, and drive cost management of clean utilities system.
• Assist or manage the contractors involved in the regular maintenance or on-site renovation activities to ensure compliance with EHS, GMP/GDP and other related regulations.
• Collect operational data and develop tools for analytics on energy usage and efficiency.
• Any other tasks as assign from time to time.

REQUIREMENTS:

• Minimum 8 years of relevant working experience in pharmaceutical or semiconductor industry.
• Experienced in PW, WFI, PS, CA, CO2, O2, LN2 specifications and familiar with local and international codes and standards.
• Team player and able to work independent with minimal supervision.
• Possess good communication, analytical, problem-solving, and troubleshooting skills.

EDUCATION
(Indicate the mini. requirement & preferred discipline):

• Bachelor degree in Environmental, mechanical engineering or equivalent.

OTHER SKILLS, ABILITIES & EXPERIENCE:

• Office tools – MS office and AutoCAD
• Experience in FDA or EU GMP audit is preferred.