職位描述
職位描述：
Principal Duties and Responsibilities
Full time maintenance for the utility and facilities of the global-standard JHL Biotech facilities in Wuhan, China. This function is responsible for both the JHL-1 commercial facility and Development Laboratory:
1. Active participation in the development and implementation of the Company Quality Management System with specific responsibility for facility systems and critical equipment: routine maintenance and response to breakdown maintenance
2. Responsible for the GMP documentation handling of DVR, CCR, CAPA for facility.
3. Management of specialist contractors and vendors to maintain PROCESS equipment.
4. Ensuring the Company’s direct-impact utilities systems are maintained in a validated state.
5. Site Facility operation and maintenance function including:
6. Buildings Maintenance Service
7. Pure Steam Systems, Compressor Dry Air systems, Specialist gas systems
8. HVAC (Classified Cleanrooms and general areas), Water for Injection systems
9. Process Glycol, Chilled water system, Cooling water system, Boiler system
10. Waste Water Treatment systems, Electrical power system (included emergency generator)
11. Preparing standard operating procedures and associated records for management and execution of the maintenance program.
Job Requirements
1. Bachelor’s Degree in Engineering or Life Science.
2. Oral and written communication skills in English and Mandarin (Read, Write, Verbal).
3. Basic knowledge and understanding of facility and utility for biopharmaceutical processes.
4. Sound knowledge of Good Engineering Practices (GEP) encompassing documentation and equipment selection for pharmaceutical facilities. Sound Understanding of Good Manufacturing Practice (GMP)
5. Knowledge of maintenance of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, and HVAC) and general building services (e.g. access control, boiler, waste neutralization, chillers, cooling towers, electrical power, emergency generators, compressed gas)
