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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 15 years of detailed design experience in pharmaceutical engineering, including at least 5 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.
Job ID: 141371883