Overseas Site Engineering Project Management

Participate in feasibility studies, site selection evaluation, master planning, and investment analysis for overseas site projects; assist in developing overall project plans, defining phase objectives, resource requirements, and key milestones to lay the foundation for design and execution.

Coordinate with design institutes and technical teams to organize reviews of conceptual, preliminary, and detailed designs, ensuring compliance with company technical standards, GMP requirements, and local regulations; track design progress and resolve technical issues in a timely manner.

Assist in developing procurement strategies and managing tendering for equipment, materials, and services; review supplier qualifications and technical proposals; participate in contract negotiations and oversee contract execution to ensure supply and service quality meet project requirements.

Supervise site construction activities including civil works, installation, and utilities; develop and monitor construction schedules, identify and resolve factors affecting timelines to ensure completion of each phase as planned.

Lead commissioning and qualification (CQV) of utility systems, production equipment, instruments, and computerized systems; review validation plans, supervise execution, and verify reports to ensure compliance with ISPE guidelines, FDA/EMA, and other international standards as well as company requirements, ensuring facilities and equipment meet production and R&D needs.

Promote EHS management during project execution to ensure construction and validation activities comply with company safety standards and local laws; organize quality inspections and acceptance to ensure engineering quality meets design and regulatory requirements.

Act as a liaison between the Company and external partners, establishing efficient communication with engineering teams, contractors, suppliers, supervisors, and regulators to promptly address technical, scheduling, and quality issues during project implementation and validation.

Oversee the preparation, review, and archiving of all project and validation documentation to ensure completeness and traceability; establish a project knowledge base for future reference and continuous improvement.

Proactively identify risks in design, construction, and validation phases, organize development of mitigation measures; conduct post-project reviews to capture lessons learned and drive continuous improvement.

Bachelor’s degree or above in Chemical Engineering, Bioengineering, Pharmaceutical Engineering, Electromechanical Engineering, Project Management, or other biopharmaceutical engineering-related fields; a master’s degree is preferred.

More than 8 years of experience in engineering construction and validation in the biopharmaceutical industry, and more than 5 years of full-process engineering project management experience; candidates with hands-on experience in schedule and cost control of overseas biopharmaceutical site construction are preferred; familiarity with the full process of factory and facility construction in CDMO/biopharmaceutical enterprises and proficiency in ISPE guidelines and GEP/GMP norms are preferred.

Ability to independently develop overall project plans, milestone schedules, and progress control systems; accurately identify deviations and implement effective corrective actions; hands-on experience in design management, procurement, construction, and handover processes.

Proficient in cost estimation, budgeting, and execution supervision; capable of cost analysis and variance alerts; able to control additional costs from design changes, procurement, and construction modifications to keep the project within budget.

Expert in full-process CQV management, with mastery of…