项目前期与规划支持
Project Early-Stage & Planning Support
代表公司参与海外基地工程项目的可行性研究、选址评估、总体方案制定及投资分析；协助编制项目总体计划，明确各阶段目标、资源需求及关键里程碑，为后续设计与实施奠定基础。
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.
设计管理与技术审核
Design Management & Technical Review
协调设计院及相关技术团队，组织方案设计、初步设计及施工图设计评审，确保设计方案符合公司技术标准、GMP要求及当地法规；跟踪设计进度，及时解决设计过程中的技术问题。
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.
采购与合同管理
Procurement & Contract Management
协助进行工程设备、材料及相关服务的采购策略制定与招标管理，审核供应商资质及技术方案；参与合同谈判与签订，监督合同执行过程，确保供货与服务质量满足项目要求。
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.
施工建设与进度管控
Construction & Schedule Control
代表公司监督施工现场管理，包括土建、安装、公用工程等环节；制定并跟踪施工进度计划，识别并协调解决影响工期的因素，确保各阶段按既定时间节点完成。
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.
工程验证全流程管理
Full-process Engineering Validation Management
主导海外基地公用系统、生产设备、仪器仪表及计算机化系统的调试与验证（CQV）工作；审核验证方案、监督执行、复核报告，确保符合ISPE指南、FDA/EMA等国际标准及公司要求，保障设施设备满足生产与研发需求。
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.
质量、安全与合规管理
Quality, Safety & Compliance Management
推动项目执行过程中的EHS管理，确保施工与验证活动符合公司安全规范及当地法律法规；组织质量检查与验收，确保工程质量满足设计及法规要求。
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.
内外部协调与问题解决
Internal & External Coordination & Issue Resolution
作为公司与外部合作方的联络桥梁，与工程团队、施工单位、供应商、监理单位、监管机构等建立高效沟通机制，及时协调解决项目实施与验证过程中的技术、进度、质量等问题。
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.
项目文档与知识管理
Project Documentation & Knowledge Management
监督工程建设与验证全过程文档的编制、审核与归档，确保数据完整、可追溯；建立项目知识库，为后续项目提供参考和经验积累。
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.
风险管控与持续改进
Risk Management & Continuous Improvement
主动识别项目在设计、施工、验证等各阶段的风险，组织制定防控措施；在项目结束后进行总结评估，推动经验反馈和流程优化。
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.
任职要求 | Job Requirements
学历与专业
Education & Major
本科及以上学历，化工工程、生物工程、制药工程、机电工程、项目管理等生物医药工程相关专业，硕士学历优先。
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.
工作经验
Work Experience
8年以上生物医药行业工程建设与验证相关工作经验，5年及以上工程项目全流程管理经验；具备海外生物医药基地建设进度与成本管控实操经验者优先；熟悉CDMO/生物制药企业厂房、设施建设全流程，精通ISPE指南、GEP/GMP规范者优先。
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.
项目管理能力
Project Management Capability
能独立制定项目总体计划、里程碑计划及进度管控体系，精准识别各阶段偏差并采取有效纠偏措施；具备设计管理、采购管理、施工管理、验收移交等全流程实操经验。
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.
成本与风险控制
Cost & Risk Control
精通项目成本测算、预算编制与执行监督，能开展成本分析与偏差预警；具备设计变更、采购、施工整改等环节的成本控制能力，确保项目在核定预算内完成。
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.
专业技术能力
Professional Technical Competence
精通生物医药工程验证（CQV）全流程管理，掌握公用系统、生产设备的验证方法；熟悉国际合规标准（FDA/EMA/ICH）及至少一个海外国家的工程建设、制药行业法规。
Expert in full-process CQV management, with mastery of validation methods for utility systems and production equipment; familiar with international compliance standards (FDA/EMA/ICH) and regulations of at least one overseas country.
证书要求
Certification Requirements
持有PMP/IPMP项目管理师证书、注册建造师/注册公用设备工程师等证书者优先；具备EHS相关认证者优先。
Holders of PMP/IPMP, Registered Constructor, Registered Utility Equipment Engineer, or EHS certifications are preferred.
语言与沟通能力
Language & Communication Skills
英语可作为工作语言，能流利开展口头沟通、商务谈判及书面文档撰写；具备优秀的跨文化沟通与协调能力，可高效对接多方主体。
English as a working language, fluent in oral communication, business negotiation, and written documentation; excellent cross-cultural communication and coordination skills.
综合能力
Comprehensive Abilities
具备优秀的统筹规划、组织协调能力，能高效整合内外部资源；责任心强、抗压能力好、结果导向；熟练使用MS Project、Primavera P6等项目管理软件及日常办公软件。
Strong planning and organizational skills, able to integrate internal and external resources efficiently; highly responsible, resilient under pressure, results-oriented; proficient in MS Project, Primavera P6, and office software.
文化契合
Cultural Fit
认同药明生物企业文化，具备良好的团队协作精神和全局意识，严格践行公司的全球质量与合规理念。
Alignment with WuXi Biologics’ corporate culture, strong teamwork spirit, holistic awareness, and commitment to global quality and compliance principles.