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Maintenance Manager (Taiwan or Wuhan)

Summary

Full time maintenance for the equipment 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:

·         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.

·         Member of the cross-functional Engineering and Validation Department.

·         Management of JHL Maintenance personnel

·         Ensuring the Company’s direct-impact equipment are maintained in a validated state.

·         Management of specialist contractors and vendors to maintain equipment.

·         First point of call for the Company’s facility systems including:

o   Bioprocessing equipment, Process Development equipment

o   HVAC (Classified Cleanrooms and general areas), Water for Injection systems

o   Pure Steam Systems, Compressor Dry Air systems, Specialist gas systems

o   Process Glycol, Chilled water system, Cooling water system, Boiler system

o   Waste Water Treatment systems, Electrical power system (included emergency generator)

Job Responsibilities

Essential functions include, but are not limited to the following:

·         Site Safety

o   Developing and maintaining a culture of safe working practices through personal leadership and establishing standard procedures for safety management.

o   Enforcing a system for job safety assessments and issuing permits-to-work including lock-out tag-out of energized and hazardous systems.  Zero lost-time injuries

·         Maintenance of Facility Systems

o   Maintaining the operational state of facility systems incompliance with Good Manufacturing Practice (GMP).

o   Preparing and managing the schedule of preventative maintenance activities for the site.  Priority being core manufacturing facility and utilities and coordination with Production and QC departments.

o   Coordination of specialist service providers and vendors to execute the maintenance program.  Breakdown repair and trouble-shooting of equipment and facilities.

o   On call (SMS) for emergency response to system alarms.

o   Issue and management of Work Orders.

o   Annual, half year, quarterly, monthly, weekly maintenance of facility systems.

o   Managing the inventory of critical spare parts to ensure that foreseen mechanical failures of utilities can be rectified within 24 hours.

o   Managing the programmed maintenance plan for the site covering cleaning and renovation of buildings and grounds to keep them in a high standard.

o   Minor redesign and capital projects to improve operation status.

·         Quality

o   Preparing standard operating procedures and associated records for management and execution of the maintenance program.

o   Raising and/or resolving investigations for quality incidents related to performance of facilities and equipment. Complying with, and continuously improving, the Company Quality Management System.

·         Design

o   Review and mark-up of design drawings to provide practical and easily maintained design. Recommend and approve preferred vendors for equipment and spares

o   Selection of critical and routine maintenance spare parts such as gas filters, HEPA filters, motors, electrical components, and chemical dosing consumables.

·         Management

o   Preparing weekly and monthly progress reports. Management of Engineers and Technicians including setting objectives, working roster, and review of performance.

o   Selection and supervision of specialist contractors and vendors.

o   Providing technical and financial input to capital expenditure requests for site improvement and renovation projects.

o   Approval of operating expenditure in line with approved budget and authority level.

Job Qualifications (Education, Certifications, Experience)

                        o   B.E. (preferably Mechanical or Electrical) plus a minimum of 5 years responsibility facility systems within pharmaceutical organization, or at least 8 year facility maintenance experience in healthcare, specialty chemicals, or food industries.

o   Detailed knowledge and hands-on experience in maintenance of facility systems.

o   Preferably experienced in operation of biopharmaceutical API facilities and exposure to facility start-up. Preferably member of ISPE, ASHRAE, and/or ASME.

o   Demonstrated experience in management of high-performance teams

·         OTHER KNOWLEDGE AND SKILLS REQUIRED:

o   Sound knowledge of Good Engineering Practices (GEP) encompassing documentation and equipment selection for pharmaceutical facilities. Sound Understanding of Good Manufacturing Practice (GMP)

o   Experienced in operation and optimization of facility systems.

o   Hands-on experienced in  knowledge 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)

o   Certified boiler attendant, Qualified in CPR.

o   Stand by on holiday and night shifts.  24hours 365 days operation facility system.

o   Experience with central facility monitoring systems (BMS)

o   Hands-on Manager/Super-user experience with a Computerized Maintenance Management Systems (CMMS) such as Blue Mountain.

o   Familiar with calibration of automated systems including SCADA, DCS, and PLC- based systems.  Ability to investigate and solve detailed technical problems.

          o Advanced document writing skills using MS Office suite.

          o Eye for detail and preference to work in highly structured manner.

 

o   Strong communication skills in English and Chinese to engage with personnel across the Company and service providers including understanding of technical documentation in English.