Process Equipment Manager
1 week ago
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.
Preventive Maintenance
Troubleshooting
FDA
HAZOP
Chromatography
GMP
Equipment Maintenance
AutoCAD
Commissioning
Autoclave
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