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Maintenance Engineer-Process Equipment
Suzhou , ChinaFacilities

ESSENTIAL FUNCTIONS


1. Active participation in the development and implementation of the Company Quality Management System with specific responsibility for critical equipment: routine maintenance and response to breakdown maintenance.

2. Member of the cross-functional Facilities Department.

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

4. Management of specialist contractors and vendors to maintain equipment.

5. Mainly First point of call for the Company’s Process Equipment including:

a. Production and Process Development equipment, Thermal Control Units. including Bioreactor, Incubator, Autoclave, Column packing station, Mixer, Washer, Freezer, BSC, Wave, AKTA chromatography system, UFDF Skid and some in-process control instruments.

6. Support facility systems including:

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

b. Pure Steam Systems, Compressor Dry Air systems, Specialist gas systems

c. Chilled water system, Cooling water system

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



QUALIFICATIONS (EDUCATION, CERTIFICATIONS, EXPERIENCE)

1. HVAC Mechanical or Electrical.

2. At least 4 years’ responsibility for direct-impact systems within a pharmaceutical organization, or at least 6 years facility maintenance experience in healthcare, specialty chemicals, or food industries.

Prefer to have worked in hands-on role at major vendors (such as GE, Thermo, Millipore, etc.) and done SAT, IOQ, Maintenance.

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

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

4. Maturity, Logical thinking.

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

Confident in hands-on work with automated mechanical systems.


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