Ensure utilities system, HVAC and electric system including but not limited to purified water system, WWT, clean steam system, compressed air system, nitrogen system, cold room, clean room and HVAC system to be in compliance with SOP, GMP and EHS requirements via routine inspection, correct utility operation and effective on-site preventive, corrective maintenance and predictive maintenance execution. 通过正确的公用工程、暖通空调统、电气系统的运行和有效的巡检,现场预防性,纠正性维护及预测性维护,保证公用设施包括但不局限于纯化水系统,废水系统,洁净蒸汽系统,压缩空气系统,氮气系统,冷库,GMP区域的洁净室和空调系统符合SOP, GMP及EHS的要求。 Through continuous optimization and improvement of operation strategy, maintenance plan, and maintenance activities to achieve operational reliability, operational performance, energy saving and efficient operation of utility systems and HVAC systems to meet the requirements of the production environment and energy media supply. 通过运行策略,维护计划,维护活动的持续优化及改善实现公用工程系统,空调系统运行可靠性,运行性能,节能高效运行,满足生产环境的要求和能源介质的供应。 Ensure the Clean utility system and HVAC system operation & maintenance, qualification, recordings, and activities are in compliance with GMP requirements (Good Manufacturing Practice for Medical Devises) and ISO 13485. 确保洁净公用系统和暖通空调系统的运行维护,系统确认,记录和相关活动符合GMP要求(医疗器械生产质量管理规范)和ISO 13485 要求。 Perform all job duties in fully accordance with: the Roche policies on information, assets life cycle management (ALCM), Roche policies on employee handbook, regulations etc. 执行所有工作的过程中需要遵守所有的罗氏和本地法规规定的信息政策、资产生命周期管理、罗氏员工手册的规定,法律法规等。 Support governance of the 3rd party service suppliers in the respective area, Supervise and ensure all activities in accordance with SOP procedure. 对第三方服务供应商的监督管理,确保所有的活动符合SOP程序要求。 Main Tasks & Responsibilities主要工作职责 : 1. Daily utility’s monitoring/problem on site confirmation/status reporting/repair. According as SOP requirements to monitor & control the EMS/BMS systems, response the alarm and take corrective action, reporting and updates the information, logbook recording and management. 公用设施系统的日常监控、故障现场确认、状态汇报和维修。EMS/BMS系统的日常监控依据SOP 的要求报警响应及汇报,日志记录及管理。 2. Keep monitoring and controlling the key parameters for clean utilities, alarm response, take corrective and preventive action, and make sure they are all in a certain range and compliant with GMP requirements. Such as temperature & humidity, microbial, particulate, dew point, oil content, bacteria, temperature, and all those defined as critical indicators based on criticality assessment. 保持对洁净系统和洁净室的关键参数的持续监控,报警响应,纠正和预防措施,确保关键参数均在标准范围内其符合GMP的要求。比如温湿度,压差,微生物,尘埃粒子和其他根据重要性的分析评估被定义为的关键指标。 3. Strictly carry out equipment daily inspection, record all parameters or findings in logbook. 严格执行设备日常巡检及预防性维护,在日志中记录各项参数及发现的问题。 4. Power supply equipment routine switch and fault handling and emergency start actions operation, including the electric system and utility system. 动力设备日常切换及故障处理,应急情况的设备紧急启动,包括电力系统和公用系统。
5. Implement the routine inspection, preventative maintenance and predictive maintenance for the site electrical system, HVAC system, clean utility system, clean room and cold room. 执行工厂内电气系统,暖通空调,公用系统,洁净室和冷库日常巡检、预防性,维护保养工作。 6. Utility system maintenance includes time & condition based for the chillers, compressors, PW generation & distribution system, air handling units, boilers, and electric heater equipment, cooling towers, etc. 基于固定周期,状态的公用系统维护包括制冷机组,压缩机,纯化水机组,废水处理设备,组合式空调机组,蒸汽锅炉,电加热设备,冷却塔,等。 7. Routine chemical solution preparation, re-filling of industrial salt for softener, Clean on the pipes and equipment surface, Carry out sanitation on the pre-treatment and RO units as scheduled, Carry out sterilization on the purified water storage tank and circulation loop as scheduled, Change filters, UV tubes and etc. as scheduled. Co-operate with QC water sampling. 日常的化学品溶液配置,软化床加盐,设备及管道表面清洁,按规定周期进行前处理及反渗透装置消毒,按规定周期进行纯化水储罐及循环管路消毒,按规定周期更换过滤器及紫外灯等耗材,协助QC取水样等。 8. Responsible for water quality sampling of wastewater system, operation of wastewater system, ensure continuous operation of wastewater system, wastewater treatment and compliance discharge. 负责废水系统的水质取样,废水系统的运行操作,确保废水系统连续运行,废水经过处理合规排放。 9. Responsible for maintenance and troubleshooting of building automation system, EMS system, instruments, controllers, actuators, sensors, electrical components, etc. 负责楼宇自控系统,EMS系统的设备,仪表,控制器,执行器,传感器,电气部件等的日常维护和故障排查。 10. Supervise the 3rd party service provider for system operation and maintain, ensure systems (equipment) are maintained in an appropriate way by following relevant procedures and GMP regulations. Make sure critical systems and equipment being maintained in qualified status all the time. 监督第三方服务供应商的对系统的运行维护活动,确保系统(设备)按照有关的程序和GMP法规进行有效合理的维护。确保关键系统和设备始终处于符合规范的状态。 11. Support project transformation activities, in terms of machinery-related requirements including the relevant technical specifications requirements, and accepted standards, such as equipment, piping material requirements, the selection of key mechanical components, equipment installation specifications and operational performance to meet the standards. 支持项目改造活动,在机械相关的要求方面可以提出相关的技术规范要求,和接受的标准,比如设备,管道的材质要求,关键机械部件的选型,设备的安装规范和运行性能满足的标准。
12. Ensuring compliance with corporate directives and local laws and regulations where appropriate. 确保相关的方面符合集团的指令要求和当地法规。 13. Responsible for utility & HVAC system’s reliability improvement, keep continuous improvement on energy saving project to meet energy saving target. 负责公用及空调系统可靠性提高,保持持续改进在节能方面达成节能目标。 14. Other tasks assigned by head of department. 部门主管交办的其他事项 15. Ensure all HVAC system, clean utility system related tasks are in compliance including quality, SHE requirements. 确保所有暖通空调系统和洁净公用系统相关的任务均符合质量,安全和卫生的要求。 16. To maintain the good 5S conditions for all machinery, include but not limited to utility equipment, HVAC equipment etc. 维持所有设备的5S管理,包括但不仅限于公用设备,暖通空调系统的设备等。 17. Responsible own certification’s review process and ensure all the certifications are valid. 负责并确保自有证书的复审,确保所有证书和资质有效。 18. Other tasks assigned by line manager. 完成直线经理交办的其他工作。