Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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

Responsibilities

Responsible for coordinating the operation and upkeep of utilities and facilities systems including HVAC, chiller, boiler, air compressor, nitrogen, WFI, and RODI systemsWork closely with the validation team to complete the qualification and re-qualification of the facilities and utilities systemsDraft and develop SOP and PM plan for facilities and utilities systemsResponsible for utilities and facilities systems related changes and deviation managementCo-operate with internal and external audit teamResponsible for leading all aspects of the implementation of minor CAPEX initiatives related to infrastructure and building systems going forwardResponsible for coordinating the shutdown plan and execution of building services and amenitiesReview 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 activitySupport the maintenance critical metric based on the site engineering and quality requirement for utilities and facilitiesEnsure the completion of all routine maintenance works as scheduled and following Engineering standards and safety proceduresAll GMP documentation related to maintenance activities is completed accurately and processed to full completion in compliance to data integrity requirementCarry out any other duties and responsibilities as assigned by line manager, including but not limited to the above

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 issuesHas working experience in using the Building Management System and Environmental Monitoring SystemUnderstanding of electrical standards and local requirements and general electrical safety standard methodologiesSAP/CMMS experience is an advantage

Competencies:

Able to work in a fast pace and a regulated environmentAble to plan, schedule, organize, prioritize, and coordinate project activityStrong understanding of facilities systems related validation / GMP requirementsStrong problem-solving skill and a good knowledge of different RCA toolsAble to work independently and to perform machine maintenance work