Process Equipment Manager

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.

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.