JOB DESCRIPTION

The incumbent will provide direction and supervision to support utilities system maintenance and operation in compliance with cGMP, EHS, Data Integrity and regulatory requirements for the new sterile manufacturing site

MINIMUM REQUIREMENTS/QUALIFICATIONS

Education:

• University degree in engineering

Experience:

• 4 to 6 years of proven experience in maintenance of utilities and facilities systems and related validation/GMP issues
• Has working experience in using the Building Management System and Environmental Monitoring System
• Understanding of electrical standards and local requirements and general electrical safety standard methodologies
• SAP/CMMS experience is an advantage

Competencies:

• Able to work in a fast pace and a regulated environment
• Able to plan, schedule, organize, prioritize, and coordinate project activity
• Strong understanding of facilities systems related validation / GMP requirements
• Strong problem-solving skill and a good knowledge of different RCA tools
• Able to work independently and to perform machine maintenance work

• Responsible for coordinating the operation and upkeep of utilities and facilities systems including HVAC, chiller, boiler, air compressor, nitrogen, WFI, and RODI systems
• Work closely with the validation team to complete the qualification and re-qualification of the facilities and utilities systems
• Draft and develop SOP and PM plan for facilities and utilities systems
• Responsible for utilities and facilities systems related changes and deviation management
• Co-operate with internal and external audit team
• Responsible for leading all aspects of the implementation of minor CAPEX initiatives related to infrastructure and building systems going forward
• Responsible for coordinating the shutdown plan and execution of building services and amenities
• Review as-built drawings and engineering technical data and performance data for the building infrastructure and utility systems.
• Support third-party vendor who is contracted to perform routine inspection, preventive maintenance, corrective maintenance and any other maintenance related activity
• Support the maintenance critical metric based on the site engineering and quality requirement for utilities and facilities
• Ensure the completion of all routine maintenance works as scheduled and following Engineering standards and safety procedures
• All GMP documentation related to maintenance activities is completed accurately and processed to full completion in compliance to data integrity requirement
• Carry out any other duties and responsibilities as assigned by line manager, including but not limited to the above