Work Location: Tuas, Singapore
Responsibilities:
- Lead the adaptation of Chinese process design schemes to Singapore regulations and building codes, optimize workshop layout, and reduce construction costs.
- Ensure that process system design complies with Singapore PIC/S GMP annex requirements and simultaneously meets FDA/EMA standards.
- Manage multinational design team collaboration (e.g., basic design by Chinese design institute + detailed construction drawings by Singapore local team) and resolve differences in process design standards.
- Review equipment from global suppliers to ensure compliance with Singapore equipment registration (SCEM) and safety certification (SCDF fire approval).
- Lead process technical decision-making during the design-construction-commissioning (EPC) phase.
- Communicate with Singapore regulatory bodies and QP(Qualified Person), respond to audit inquiries, and ensure the progress of drawing approvals.
- Train the Singapore design team to understand Chinese technical documents and ensure consistency in process design.
- Coordinate multidisciplinary design interfaces such as process, automation, electrical, and HVAC, and resolve system conflicts.
- Review process-related construction drawings provided by contractors to ensure technical details meet URS (User Requirement Specification).
- Responsible for daily management, work allocation, performance evaluation, and motivation of the process design team.
- Guide and train team members to improve the technical level of process design foster a positive team atmosphere and promote team collaboration.
Requirements:
- Bachelor's degree or above, major in pharmaceutical engineering, chemical engineering, bioengineering, or mechanical design
- Good written and spoken Chinese and English, able to communicate fluently on technical matters with both Singapore local and Chinese technical teams.
- Over 10 years of detailed design experience in pharmaceutical engineering, including at least 3 years of process design experience in pharmaceutical construction projects.
- Full participation in at least one pharmaceutical project with an investment of over 50 million RMB (sterile preparation/biopharmaceutical projects preferred).
- Proficient in 3D design software (PDMS/AVEVA E3D) and stress analysis tools (CAESAR II).
- Familiar with compliance management platforms (such as ACC drawing management platform).
- Good planning, summarizing, communication, and coordination skills.
- Strong independent judgment and problem-solving abilities.
- Strong verbal and written communication skills.
- Logical analysis ability: strong logical thinking and ability to promptly assess and grasp the development of situations
- Time management ability: strong time management skills and a planned approach to work
- Cost awareness: clear sense of cost, able to work under pressure, and continuously optimize processes.
