1.2-1.3万
罗氏诊断产品(苏州)有限公司1
Key
Responsibilities工作职责:
1. 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。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.
2. 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。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.
3. 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。Strictly carry out equipment daily inspection, record all parameters
or findings in logbook.
4. 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。Power supply equipment routine switch and fault handling and emergency
start actions operation, including the electric system and utility system.
5. 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。Implement the routine inspection, preventative maintenance and
predictive maintenance for the site electrical system, HVAC system, clean
utility system, clean room and cold room.
6. 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。 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.
7. 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。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.
8. 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。Responsible for water quality sampling of wastewater system, operation
of wastewater system, ensure continuous operation of wastewater system,
wastewater treatment and compliance discharge.
9. 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。Responsible for maintenance and troubleshooting of building automation
system, EMS system, instruments, controllers, actuators, sensors, electrical
components, etc.
10. 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。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.
11. 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。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.
12. 确保相关的方面符合集团的指令要求和当地法规。Ensuring compliance
with corporate directives and local laws and regulations where appropriate.
13. 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。Responsible for utility & HVAC system’s reliability improvement, keep continuous improvement on energy
saving project to meet energy saving target.
14. 部门主管交办的其他事项Other tasks assigned by head of department.
15. 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。Ensure all HVAC system, clean utility system related tasks are in
compliance including quality, SHE requirements.
16. 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。To maintain the good
5S conditions for all machinery, include but not limited to utility
equipment, HVAC equipment etc.
17. 负责并确保自有证书的复审,确保所有证书和资质有效。Responsible own
certification’s review process and ensure all the certifications are valid.
18. 完成直线经理交办的其他工作。Other tasks assigned
by line manager.
Required
Knowledge and Skills职位要求:
1. 有2~3年厂务设施设备维护经验。2~3 years experience
in facility maintenance.
2. 有使用MS Office办公软件,Excel,, Word的经验.Experience with MS Office tools s.a. Excel,
Powerpoint, Word.
3. 熟悉空调系统和洁净公用系统的工作原理,了解系统设计。Familiar with HVAC and
CU system operation principles, understanding of HVAC system design.
4. 熟悉机械相关的通用设备的结构及工作原理,丰富的机械维修和故障排查的工作经验。Familiar with the structure and working principle of mechanical
related utility equipment, rich working experience in mechanical maintenance
and troubleshooting.
5. 熟悉故障根本原因分析方法论。Familiar with problem
solving methods
6. 项目管理技能。良好的理解调试和验证过程与活动 Project management skills. Good
understanding of the commissioning and qualification process and activities
优先考虑:
1, 2~3年cGMP行业工作经验。2~3 years experiences in a highly regulated cGMP manufacturing
environment.
2, 有2~3年厂务设施设备维护经验。2~3 years experiences
in facility PM management
3, 有使用MS Office办公软件,Excel, Powerpoint, Word的经验.Experience with MS Office tools s.a. Excel, Powerpoint, Word.
4, SAP 经验SAP experience
5, 实现结果Achieving Results
6, 团队精神和协作Teamwork and Collaboration
7, 激励和影响Inspiring and Influencing
Qualifications
and Education 学历资质:
1,中专学历或者具有同等职业能力和知识Technical secondary school or have similar job/working
skills/knowledge
2,拥有低压电工证,制冷证,锅炉证Refrigeration, Electrician certificate, boiler
operation license.
优先考虑:
1,大专学历 College
degree
2,拥有中级或高级技师证书Middle grade or senior technician certificate
以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕