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Engineer, Operation & Maintenance
Suzhou , ChinaFacilities

Essential functions include, but are not limited to the following:
Site Safety
1. Contributing to the safe operation of CMAB facilities through personal initiative and adherence with Company procedures.
2. Zero lost-time injuries
3. Maintenance of Facility Systems/
4. Maintaining the operational state of facility systems incompliance with Good Manufacturing Practice (GMP).
4. Coordination of specialist service providers and vendors to execute the maintenance program.
5. Breakdown repair and trouble-shooting of equipment and facilities.
6. On call (SMS) for emergency response to system alarms.
7. Replacement of parts to keep facility normal operation
8. Annual, half year, quarterly, monthly, weekly maintenance of facility systems.
9. Managing inventory of critical spare parts for facility systems and critical instruments.
10. Minor redesign and capital projects to improve operation status.


Quality
1. Preparing standard operating procedures and associated records for management and execution of the maintenance program.
2. Complying with, and continuously improving, the Company Quality Management System.


Design
1. Review and mark-up of design drawings to provide practical and easily maintained design.
2. Recommend and approve preferred vendors for equipment and spares.
3. Selection of critical and routine maintenance spare parts such as gas filters, HEPA filters, motors, electrical components, and chemical dosing consumables.


QUALIFICATIONS (EDUCATION, CERTIFICATIONS, EXPERIENCE)
1. B.E. (preferably Electrical power or mechanical) plus a minimum of 2 years responsibility facility systems within pharmaceutical organization
2. Or at least 5 years facility maintenance experience in healthcare, specialty chemicals, FAB, or food industries.
3. Detailed knowledge and hands-on experience in maintenance of facility systems.
4. Preferably experienced in operation of biopharmaceutical API facilities and/or aseptic fill-finish and exposure to facility start-up.


OTHER KNOWLEDGE AND SKILLS REQUIRED:
1. Sound knowledge of Good Engineering Practices encompassing documentation and equipment selection for pharmaceutical facilities.
2. Sound Understanding of Good Manufacturing Practice (GMP)
3. Experienced in operation and optimization of facility systems.
4. Advanced hands-on skills in maintenance of equipment and replacement of spare parts.
5. Ability to investigate and solve problems.
6. Prefer to have Licenses for facilities operation such as: Low voltage, pressure vessel, boiler attendant, forklift operation, safety operation.
7. Qualified in CPR
8. Stand by on holiday and midnight 24hours 365days operation facility system
9. Experience with facility monitoring systems (prefer Siemens)
10. Familiar with maintenance of automated systems including Siemens PLCs
11. Sound communication skills in English and Chinese to engage with personnel across the Company and service providers including writing technical documentation in English.




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