职位描述
Education Background: 教育背景
1.Bachelor degree in Engineering, Mechanical or Automation.
2.Education/training in GMP regulations, LEAN .
3.Good English in oral and written
Professional Experience专业经验:
1.Minimum 5 years’ of experience from a similar position
2.Experience in automation and mechanical areas
3.Experience from a production environment – working with highly automated machines.
4.Knowledge from a GMP/ISO 9001/ISO 13485 regulated production.
5.Work experience from an international company Professional experience
Main Job Tasks岗位职责:
1. Take responsibility of the owner of machines
Ensure all machine troubleshooting timely, help and instruct technicians to do troubleshooting when machine have some difficult issue. Ensure EPE department fulfil her target in relation to machine down time and scrap rate, The engineer is responsible for safety when working with machine.
2. NC root cause analysis
When NC or high scrap rate happen on production line, the responsible engineer will investigate the root cause and cooperate with Quality Support Engineers, Process Engineers, component team together to try to close it by using A3, 5 WHY, Fishbone and some c-LEAN tools systematically.
3.Machine improvement and optimization (CR handling)
When machine have some production risk, high scrap rate, machine down time caused by design, unreasonable method, within-SPEC but bad components, the responsible engineer will seek for machine improvement and optimization method through contacting supplier of OEM supplier, when doing this require CR, the engineer will support to finalize CR case to handle the whole process from the beginning to the end of machine update.
4. Participate the new project and new machine. (design and test review, test, validation)
The engineer will involve new project and new machine introduction at the early beginning of project of new machine; this will reduce potential risk for future real mass production greatly. The engineer will participate design review and test review so that some error can be found earlier. The engineer will execute test and validation including FAT, SAT, IQ, OQ, PQ. Through doing those work, our engineer will accumulate enough practical experience and are more familiar with those machine they will work together instead of only have to accept and repair those machine without any ideas about them.
5.Machine Spare parts and PM management in SAP.
The responsible engineer must insure all machine preventive maintenance is done according to SOP requirement, passing all internal and external audits without any findings about SOP compliance. The responsible engineer also must insure all machine have enough spare parts to for fear long time machine down time, this include spare parts safety quantity definition and complete spare parts list of all machine.
6. Keeping process in compliance with safety, production or quality requirements/standards.
For that difficult and key issue of machine that need technicians pay attention to, the responsible engineer will give them enough training on how to do it correctly. Another task is to insure all PM are closed in SAP system and all PM record are signed and kept well, When they found any unreasonable contents comparing with real machine running situation, the responsible engineer must update all SOP timely, this is SME responsibility. The engineer must help EHS represents to finish yearly WPA and no safety issue happen on daily work.
企业介绍
在诺和诺德,我们致力于改变,通过改变来攻克糖尿病以及其他严重的慢性病。
诺和诺德拥有90多年的历史,是一家始终致力于创新的公司,是糖尿病领域的领先者。在糖尿病领域的经验也让我们可以为更多受其他慢性病困扰的人们提供服务,如:血友病、生长激素紊乱和肥胖症。
公司总部位于丹麦首都哥本哈根,在全球75个国家和地区拥有近4万名员工(数字截至2015年6月),产品行销180余个国家和地区。
诺和诺德(中国)制药有限公司是总部于1994年在华成立的全资子公司,注册地点座落于天津经济技术开发区。