Equipment Engineer

Summary This role ensures Drug Product (DP) process equipment for commercial scale manufacturing operations performs optimally for long-term manufacturing success. The role will collaborate cross-functionally, troubleshoot technical challenges, and drive innovative solutions to enhance production efficiency and equipment reliability, while maintaining compliance with industry regulations and GMP standards. Location : Tuas Biomedical Park (Company shuttle bus is provided islandwide) Operational Phase (Primary Role) • Oversee and improve ongoing maintenance and operational reliability of drug product process equipment. • Implement asset management systems to track maintenance schedules, spare parts, and costs. • Ensure all equipment requiring statutory inspections are scheduled and tracked in CMMS systems (e.g., Maximo). • To diagnose equipment malfunctions, analyze root causes of failures, implement corrective actions, and optimize equipment performance through continuous improvement initiatives. • Train maintenance teams on new procedures, troubleshooting, and safety protocols. • Set up and maintain a maintenance workshop equipped with the necessary tools and procedures. • Regularly review maintenance data to identify areas for process improvement and cost reduction. • Establish protocols for handling downtime, emergency maintenance, and system failures promptly. • Support continuous improvement initiatives and implement design enhancements based on operational feedback. • Maintain strict compliance with GMP standards and safety regulations, ensuring no significant findings during inspections. • Facilitate the transition from project completion to full operational status, ensuring a seamless handover. Project Phase (Initial Role) • Provide technical expertise during the design phase to ensure equipment meets all operational requirements including performance, maintenance, and reliability. • Collaborate with design team and vendors to establish maintenance strategies, spares availability, and service contracts. • Develop and maintain engineering documentation (e.g., equipment specifications, preferred vendor lists, P&IDs, equipment layouts). • Support technical evaluation during procurement stage by reviewing equipment data sheets, P&IDs, and technical requirements. • Lead the development of bidding documents, vendor evaluations, and bidding processes as package owner. • Participate in key commissioning activities including system checks, lubrication, alignment, and performance testing to ensure equipment meets operational standards. • Work closely with QA and Qualification teams to review commissioning and qualification documentation. • Troubleshoot and resolve commissioning issues and discrepancies. • Support or execute qualification tests and inspections according to approved protocols. Document qualification results and deviations, and ensure compliance with validation requirements. • Review qualification reports and support final approval processes. • Conduct technical inspections to support handover, ensuring system functionality and compliance. Requirements • Bachelor Degree in Mechanical engineering, mechatronics or related • Minimum 3-5 years of relevant experience in process/manufacturing equipment engineering within biopharmaceutical, pharmaceutical, or biotech manufacturing. • Hands-on experience with bioreactors, chromatography skids, ultrafiltration systems, CIP skids, drug product filling lines, Lyophilizers, automated visual inspection machines and other DP/DS process equipment is highly desirable. • Strong understanding of GMP, biopharmaceutical manufacturing processes, and equipment • validation. • Strong understanding of mechanical principles, components, and systems related to production equipment such as agitators, motors, pumps, conveyors, gears, mechanical seals and bearings etc. • Familiar with computerized maintenance system (e.g. Maximo or others) • Demonstrated ability to engage with internal and/or external auditors on production equipment matters and ensure prompt follow-up on CAPA (Corrective and Preventive Actions) actions post audit. • Proficient in office productivity tools, AutoCAD, and other relevant engineering software used for design, documentation, and analysis. • Possess strong collaboration and communication skills, with the ability to work effectively across teams and be open to short-term business travel, both domestically and internationally.