Process Equipment Manager

3 weeks ago


Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time
Roles & Responsibilities

Responsibilities

  • Review and check deliverables of process equipments system produced by project team or contractors.
  • Support and participate in installation, testing and commissioning activities of process equipment, working closely with internal stakeholders, vendors, and contractors to ensure systems are installed correctly and function as intended.
  • Review technical drawings, specifications, URS and related document for equipment and systems, including filling line, lyo, autoclave, parts washer and TCU etc.
  • Participate in system startup, shake down, pre startup check and commissioning of the engineering and process systems.
  • Develop technical specifications and scopes of work for project team, engineering firms and contractors.
  • Liaise with other business units, sub-contractors and suppliers as appropriate in order to backing the project.
  • Collaborate with project team to set-up training documents for maintenance personnel.
  • Work with stakeholders and users to ensure a smooth handover of process equipment system.
  • Daily maintenance, preventive maintenance, on-site emergency maintenance, and shutdown maintenance of Drug Substance and Drug product equipment (vial thaw, bio-reactor, DF, centrifuge, chromatography, vial washing, tunnel oven, filling, freeze-drying machines, automatic feeding and discharging machines, isolators), as well as management of spare parts
  • Responsible for daily equipment inspection and preventive maintenance, and timely recording in the Maximo system.
  • Provide support for process equipment commissioning and verification work, including related HAZOP, HAZID, FMEA, CMMS, SOPs and regulation requirements
  • Propose improvement plans for the existing equipment
  • Based on the equipment situation, propose reasonable spare parts procurement suggestions
  • Organize engineering analysis of existing equipment, continuously improve equipment operation status, efficiency, and ergonomics, and promote cost savings
  • Responsible for writing and updating SOP documents for process equipment maintenance
  • Participate in relevant deviation investigations, maintain communication with other departments, and constantly find new opportunities for improvement
  • Timely and truthfully keep operation records, maintenance records, and upkeep records, and archive them
  • Organize and analyze equipment operation data, solve various equipment failures, reduce equipment downtime, and lower equipment failure rates
  • Other tasks assigned by superiors.


Requirements

  • Bachelor degree in environmental, mechanical engineering or equivalent
  • Minimum 8 years of relevant working experience in pharmaceutical industry.
  • Experienced in Drug Substance and Drug product equipment specifications and familiar with local and international codes and standards.
  • Have work authorization in Singapore.
  • Proficient in English (written & oral) and Chinese(oral) will be an added advantage.
  • Team player and able to work independent with minimal supervision.
  • Possess good communication, analytical, problem-solving, and troubleshooting skills.
  • Experience with office tools: MS office and AutoCAD
  • Experience in FDA or EU GMP audit preferred.

Tell employers what skills you have

Preventive Maintenance
Troubleshooting
FDA
HAZOP
Chromatography
GMP
Equipment Maintenance
AutoCAD
Commissioning
Autoclave

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