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A global scientific services provider in Singapore seeks an experienced professional to oversee the maintenance and operation of utilities systems in compliance with GMP and regulatory standards. Candidates should possess a degree in engineering and 4-6 years of relevant experience. Strong problem-solving skills and regulatory knowledge are essential for success in this role. Join our team to support our advanced sterile manufacturing site.
Standard (Mon-Fri)
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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
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
Education:
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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.