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.
