洁净公用高级经理(PW/WFI/CU)hz

/ Job Description 负责厂房洁净公用设施及水系统的整体管理与运维，包括洁净水系统、废水处理系统及厂区给排水系统，建立安全、稳定、合规及高效的水系统管理体系，保障生产需求并持续提升系统可靠性与运行效率。 Responsible for overall management and operation of clean utility and water systems, including clean utility systems, wastewater treatment systems, and site water supply and drainage systems, establishing a safe, reliable, compliant, and efficient management system to support production and continuously improve system performance and efficiency. ________________________________________ 岗位职责 / Job Responsibilities 1. 水系统管理体系建设 建立并持续优化洁净公用设施及水系统管理体系。 Establish and continuously optimize management systems for clean utilities and water systems. 制定运维标准、操作规程及技术规范，推动标准化管理。 Develop O&M standards, SOPs, and technical guidelines to drive standardization. 确保系统符合GMP、EHS及相关法规要求。 Ensure compliance with GMP, EHS, and regulatory

. ________________________________________

2. 02

   洁净公用设施系统管理 负责纯化水、注射用水、洁净蒸汽及相关系统的运行与维护。 Manage operation and maintenance of clean utility systems such as purified water, WFI, and clean steam. 确保系统稳定运行并满足生产要求。 Ensure stable operation and meet production requirements. 参与系统验证及再验证工作。 Support system qualification and requalification activities. ________________________________________

3. 03

   废水处理系统管理 负责厂区废水处理系统的运行与维护。 Manage operation and maintenance of wastewater treatment systems. 确保废水排放符合环保及法规要求。 Ensure compliance with environmental regulations and discharge standards. 持续优化处理效率及运行成本。 Continuously improve treatment efficiency and cost performance. ________________________________________

4. 04

   厂区给排水系统管理 负责厂区供水、排水及相关基础设施的管理。 Manage site water supply and drainage systems and related infrastructure. 保障生产及生活用水稳定供应。 Ensure stable supply of process and domestic water. 优化系统运行及资源利用效率。 Optimize system performance and resource utilization. ________________________________________

5. 05

   故障管理与可靠性提升 主导水系统及相关设施的故障排查与应急响应。 Lead troubleshooting and emergency response for water systems. 开展根因分析并推动CAPA实施。 Conduct root cause analysis and implement CAPA. 持续提升系统可靠性及稳定性。 Continuously improve system reliability and stability. ________________________________________

6. 06

   工程项目与系统改造管理 负责水系统相关工程建设及改造项目支持。 Support engineering construction and retrofit projects for water systems. 参与设计评审、施工、调试及交付。 Participate in design review, construction, commissioning, and handover. 确保项目符合GMP及验证要求。 Ensure compliance with GMP and qualification requirements. ________________________________________

7. 07

   合规与审计支持 确保所有系统运行符合GMP及法规要求。 Ensure all operations comply with GMP and regulatory requirements. 支持内外部审计及检查。 Support internal and external audits. 负责偏差、变更及CAPA管理。 Manage deviations, change control, and CAPA. ________________________________________

8. 08

   团队管理与协作 建立并管理洁净水及水系统团队。 Build and manage the clean utility and water systems team. 与生产、QA、工程等部门协同。 Collaborate with Production, QA, and Engineering teams. 提升团队技术能力及执行效率。 Enhance team capability and execution efficiency. ________________________________________

9. 09

   成本与资源管理 负责系统运维预算及成本控制。 Manage O&M budget and cost control. 优化备件及资源配置。 Optimize spare parts and resource allocation. ________________________________________ 任职要求 / Job Requirements 教育背景 / Education 本科及以上学历，环境工程、给排水、化工、暖通或相关专业。 Bachelor’s degree or above in Environmental Engineering, Water Supply & Drainage, Chemical Engineering, HVAC, or related fields. ________________________________________ 工作经验 / Experience 8年以上制药或相关行业水系统或公用设施经验。 Minimum 8 years of experience in water systems or utilities in pharmaceutical or related industries. 具备洁净公用设施系统经验。 Experience in clean utility systems is required. 具备废水处理或给排水系统管理经验。 Experience in wastewater treatment or water supply/drainage systems. 具备团队管理经验优先。 Leadership experience is preferred. ________________________________________ 专业能力 / Technical Competence 熟悉纯化水、注射用水及洁净蒸汽系统。 Familiar with purified water, WFI, and clean steam systems. 熟悉废水处理工艺及环保要求。 Familiar with wastewater treatment processes and environmental regulations. 熟悉厂区给排水系统运行。 Familiar with site water supply and drainage systems. 具备系统故障分析及优化能力。 Strong troubleshooting and optimization capability. 熟悉GMP及法规要求。 Familiar with GMP and regulatory requirements. ________________________________________ 综合能力 / Soft Skills 具备良好的领导力及跨部门协作能力。 Strong leadership and cross-functional collaboration skills. 具备系统性思维及持续改进能力。 Strong systematic thinking and continuous improvement capability.