（Sr.）Clean Utility Engineer/(高级)洁净公用工程工程师

1. 01

   项目设计与建设管理 Project Design and Construction Management 负责洁净公用工程及废水处理系统的新建、扩建和改造项目设计与实施。 Lead the design and execution of new construction, expansion, and retrofit projects involving Clean Utility and wastewater treatment systems. 参与URS编制、设计审查（Conceptual Design、Basic Design、Detailed Design）及技术方案评估。 Participate in URS development, design reviews (Conceptual, Basic and Detailed Design), and technical evaluations. 审核PFD、P&ID、设备布置图、管道图及相关技术文件。 Review PFDs, P&IDs, equipment layouts, piping drawings, and related technical documents. 协调设计院、供应商、施工单位及内部利益相关方，推动项目按计划执行。 Coordinate engineering firms, vendors, contractors, and internal stakeholders to ensure project execution according to schedule. 负责FAT、SAT、调试、试运行及项目移交工作。 Support FAT, SAT, commissioning, startup, and project handover activities.

2. 02

   系统运营与维护 System Operation and Maintenance 负责洁净公用工程及废水处理系统安全、稳定、可靠运行。 Ensure safe, compliant, and reliable operation of Clean Utility and wastewater treatment systems. 制定并持续优化预防性维护计划及年度检修策略。 Develop and optimize preventive maintenance programs and annual shutdown strategies. 分析和解决系统运行中的技术问题和异常事件。 Troubleshoot operational issues and implement effective technical solutions. 管理供应商服务及维保活动，确保服务质量和合规性。 Manage vendors and maintenance service providers to ensure service quality and compliance. 推动设备可靠性提升、能耗优化及运营成本改善。 Drive equipment reliability improvement, energy optimization, and cost-efficiency initiatives.

3. 03

   系统验证与合规管理 Qualification and Compliance Management 参与洁净公用工程及相关系统的DQ、IQ、OQ、PQ活动。 Support DQ, IQ, OQ, and PQ activities for Clean Utility systems and associated facilities. 编写、审核和执行验证文件。 Prepare, review, and execute qualification and validation documentation. 确保系统符合GMP、FDA、EU GMP、ISPE及公司标准要求。 Ensure compliance with GMP, FDA, EU GMP, ISPE, and company standards. 支持监管机构检查、客户审计及内部审计。 Support regulatory inspections, customer audits, and internal audits. 负责偏差调查、CAPA、变更控制及风险评估相关工作。 Manage deviation investigations, CAPAs, change controls, and risk assessments.

4. 04

   持续改进与技术支持 Continuous Improvement and Technical Support 主导公用工程及废水系统持续改进项目。 Lead continuous improvement initiatives for utility and wastewater systems. 运用数据分析识别系统优化机会并推动实施。 Utilize operational and performance data to identify and implement optimization opportunities. 为生产、验证、质量及工程团队提供技术支持。 Provide technical support to Manufacturing, Validation, Quality, and Engineering teams. 参与新技术、新设备及数字化解决方案的评估和导入。 Participate in the evaluation and implementation of new technologies, equipment, and digital solutions. 参与跨基地项目和技术标准推广工作。 Support cross-site projects and deployment of engineering best practices and standards. 负责系统范围 / Systems Covered PW（Purified Water）纯化水系统 WFI（Water for Injection）注射用水系统 Clean Steam 洁净蒸汽系统 Compressed Air 洁净压缩空气系统 Nitrogen 氮气系统 Process Gases 工艺气体系统 CIP/SIP系统 洁净公用工程储罐及分配系统 热水及冷却系统 生物制药工业废水处理系统（WWTP） 中和系统、废液收集系统及相关环保设施 任职资格 / Qualifications 教育背景 Education 本科及以上学历，化学工程、制药工程、生物工程、机械工程、过程工程、环境工程或相关专业。 Bachelor's degree or above in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, Mechanical Engineering, Process Engineering, Environmental Engineering, or related disciplines. 工作经验 Experience 3年以上生物制药、制药、化工或相关行业工程经验。 Minimum 3 years of engineering experience in biotechnology, pharmaceutical, chemical, or related industries. 具有洁净公用工程系统项目建设、调试或运营维护经验。 Hands-on experience in Clean Utility project execution, commissioning, operation, or maintenance. 具有废水处理系统运营或项目经验者优先。 Experience with wastewater treatment systems is preferred. 专业技能 Technical Skills 熟悉PW、WFI、Clean Steam、压缩空气、工艺气体等洁净公用工程系统。 Strong knowledge of PW, WFI, Clean Steam, compressed air, and process gas systems. 熟悉废水处理工艺及相关环保法规要求。 Familiar with wastewater treatment processes and environmental compliance requirements. 熟悉ASME BPE、ISPE Baseline Guide、FDA及EU GMP相关要求。 Familiar with ASME BPE, ISPE Baseline Guides, FDA, and EU GMP requirements. 能够阅读和审核P&ID、设备图纸及工程技术规范。 Ability to read and review P&IDs, engineering drawings, and technical specifications. 具备偏差调查、CAPA、变更控制及风险评估经验。 Experience in deviation investigation, CAPA, change control, and risk assessment. 语言能力 Language Skills 具备良好的中英文沟通能力。 Good communication skills in both Chinese and English. 能够阅读英文技术文件并参与跨区域技术交流。 Ability to review technical documentation in English and support cross-regional collaboration. 优先条件 / Preferred Qualifications 具有生物制药生产基地项目建设经验。 Experience in biopharmaceutical facility construction or expansion projects. 具有大型洁净公用工程系统设计或运营经验。 Experience in large-scale Clean Utility system design or operation. 熟悉BMS、EMS、SCADA、PLC或相关自动化系统。 Familiarity with BMS, EMS, SCADA, PLC, or related automation systems. 具有FDA、EMA或国际客户审计支持经验。 Experience supporting FDA, EMA, or international customer inspections. 工作地点 / Location 江苏或浙江地区药明生物基地（能接受公司地点安排） WuXi Biologics Manufacturing Sites in Zhejiang Province or Jiangsu Province(as required)

, operation, maintenance, and continuous improvement. Ensure systems comply with GMP, EHS, quality, and business requirements while providing reliable engineering support for biopharmaceutical manufacturing. 主要职责 / Key