岗位职责:
Responsible for:
1.Contribute to new and improvement projects for good quality in the projects, including of creation of requirement specification, analysis of feature specification from vendor, and lead sub projects.
2.Coordinate equipment on-site installation (IQ/OQ)
3.Lead production process pre-studies and relevant validations/qualifications (PQ, PV).
4.Develop production process system from documentation (PMF, SOP, BPR, WI etc.) to execution.
5.Establish & keep on-time update of production process database.
6.Follow up process activities through daily monitoring.
7.Ensure sufficient trainings to shop-floor people.
8.Organize product and process investigation in case of deviation, propose and follow up corrective and preventative s.
9.Analyze production technical problems and quality deviations, lead improvement projects.
10.Analyze production efficiency and losses etc, to drive continuous improvement.
任职资格:
Education 教育背景:
Bachelor of science in pharmaceutical
Work experience工作经验:
At least 3 years working experience in a pharma or medical device manufacturing plant.
Played a role of process or production technology in manufacturing or engineering department.
Experience of sterilized liquid process.
Experience of validations
Competence and skills技能技巧:
Strong competence in production system.
Good skills in PC, MS office
Very good in GMP and ISO 13485
Familiar with Lean manufacturing: 5s, six Sigma, Value Stream Design and others


Others其它:
Very good English in speaking and writing,
German skills will facilitate your work a lot.
Target-oriented working,
Creative thinking,
Very communicative

德国费森尤斯集团是世界500强企业之一，为全球性的医疗保健服务公司，由五个在世界范围内独立运作的事业部组成：费森尤斯医药用品、费森尤斯卡比、费森尤斯医院、费森尤斯工程、费森尤斯生物技术。
费森尤斯医药用品有限公司事业部是当今世界最大的慢性肾衰竭产品和服务的供应商，是全球透析治疗的领导者。
我们的目标：每天，为全世界的人们创造一个值得生活的未来。
江苏费森尤斯医药用品有限公司是德国费森尤斯集团在中国投资的独资企业。公司成立于2007年7月17日，位于常熟市古里工业园区。公司集研发和生产功能于一体，主要生产用于血液透析配套产品，产品主要面向国际市场销售，部分产品面向国内市场。目前总投资9402万美元，员工1000多人。
由于公司不断增加的新项目和订单需求，现我们诚邀那些勤奋敬业、不断超越自我的专业人才加入我们的团队，共创伟业！
公司提供良好的培训和发展空间，同时您也可以领略到多国文化的和谐共处，提高自己的外语水平和国际视野。另外，公司还提供免费宿舍、免费工作餐及常熟市内／苏州班车、年底绩效奖金、带薪年假及其他欧美独资企业待遇。