Summary

Full time maintenance for the equipment and facilities of the global-standard JHL Biotech facilities in Taiwan. This function is responsible for both the Centre of Excellence in Chubei and the small Development Laboratory in Nangang:

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 mainteance.

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:

Bioprocessing equipment

Process Development equipment

HVAC (Classified Cleanrooms and general areas)

Highly Purified Water system

Pure Steam System

Compressor Dry Air system

CO2 & O2 distribution systems

Process Glycol

Chilled water system

Cooling water system

Boiler system

Vacuum drain system

Waste Water system

Electrical power system (included emergency generator)
Job Responsibilities

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

Site Safety

Contributing to the safe operation of JHL Biotech facilities through personal initiative and adherence with Company procedures.

Zero lost-time injuries

Maintenance of Facility Systems

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

Coordination of specialist service providers and vendors to execute the maintenance program.

Breakdown repair and trouble-shooting of equipment and facilities.

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

Replacement of parts to keep facility normal operation

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

Managing inventory of critical spare parts for facility systems and critical instruments.

Minor redesign and capital projects to improve operation status.

Quality

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

Complying with, and continuously improving, the Company Quality Management System.

Design

Review and mark-up of design drawings to provide practical and easily maintained design.

Recommend and approve preferred vendors for equipment and spares

Selection of critical and routine maintenance spare parts such as gas filters, HEPA filters, motors, electrical components, and chemical dosing consumables.
Job Qualifications (Education, Certifications, Experience)

B.E. (preferably Electrical power or mechanical ) plus a minimum of 2 years responsibility facility systems within pharmaceutical organization

Or at least 5 year facility maintenance experience in healthcare, specialty chemicals, FAB, or food industries.

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

Preferably experienced in operation of biopharmaceutical API facilities and exposure to facility start-up.

Sound knowledge of Good Engineering Practices encompassing documentation and equipment selection for pharmaceutical facilities.

Sound Understanding of Good Manufacturing Practice (GMP)

Experienced in operation and optimization of facility systems.

Advanced hands-on skills in maintenance of equipment and replacement of spare parts.

Ability to investigate and solve problems.

Certified boiler attendant

Qualified in CPR

Stand by on holiday and midnight.

24hours 365days operation facility system

Experience with facility monitoring systems (iFix)