Process Equipment Engineer

Process equipment engineer is responsible for support and coordination of Process Equipment installation, testing and commissioning of process equipment together with project team during the construction phase, and leading maintenance activity in operation phase. You are required to manage maintenance and renovation works in the fields of process equipment on site, with the necessary guidance and direction from XSEM department, to achieve site and company goals. About the Role Key accountabilities include managing the installation, testing, and commissioning of process equipment, as well as leading maintenance activities during the operational phase. Responsibilities Project Construction Phase: Review and check deliverables of process equipment 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 documents 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 back the project. Collaborate with project team to set-up training documents for maintenance personnel. As maintenance role, work with stakeholders and users to ensure a smooth handover of process equipment system. Operational Phase: 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. Qualifications 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. Team player and able to work independently with minimal supervision. Possess good communication, analytical, problem-solving, and troubleshooting skills. Education Bachelor degree in Environmental, Mechanical Engineering or equivalent. Required Skills Office tools – MS office and AutoCAD. Preferred Skills Experience in FDA or EU GMP audit is preferred. #J-18808-Ljbffr