上海招聘

职位描述：
Basic Purposes & Scope : 工作主要目的和范围
1. To perform routine bio testing for tissue project, including solution bioburden, tissue bio-burden,etc 按照流程要求，实施日常微生物实验
2. To conduct fresh tissue Validation, solution system Validation, Test Method Validation equipment qualification according to protocols
根据给定的草案，实施灭菌验证，洁净室验证，测试方法验证和微生物实验设备验证。
3. Be responsible for data collection, analysis and initiate CAPA or improvement accordingly
负责收集数据，分析并启动CAPA或相应改善活动。

Main responsibilities & duties主要职责和任务
1. Perform Clean Room Validation, fresh tissue validation, solution system validation, LAL testing system validation, Test Method Validation and Microbial equipment qualification according to protocol, and finish validation reports.
根据草案，实施洁净室验证，生物组织验证，试剂系统验证，热原测试系统验证，测试方法验证和微生物实验设备验证，并完成报告。
2. Set up test procedure/methods
建立测试流程和方法
3. Finish routine testing timely and follow up deviations found from routine testing
按时完成日常工作，对日常的测试偏差进行跟踪
4. Well maintain testing record/reports
良好保存记录/报告
5. Train bio-technician about above testing.
培训技术员上述测试要求
6. Be responsible for data collection, maintain high quality system and drive any improvement accordingly
负责收集数据，维护良好的质量系统并启动相应改善活动


JOB SPECIFICATIONS 职位要求
1. Bachelor of Science majored in Microbiology or related 本科学历，生物或相关专业
2. 2 years working experience in microbiology lab within pharmaceutical or medical industry 制药或医疗行业，2年微生物实验室工作经验
3. Master testing procedure/method of microbial testing, e.g. environmental monitoring, bio-burden test, sterility test and others related
掌握微生物实验测试流程/方法，例如，环境监测，生物负载测试，无菌检测或其他相关实验。
4. Have experience on Clean Room Validation, Test Method Validation and Microbial equipment qualification
具备洁净室验证，测试方法验证和微生物实验设备验证经验
5. Understand requirements of clean room and sterilization from microbial aspect
了解洁净室和灭菌相关的微生物要求
6. - Familiar with Organism identification or chemical sterilization as a plus
熟悉微生物菌种鉴定或化学灭菌法的优先考虑 举报 分享

柯惠医疗器材制造（上海）有限公司即美敦力上海工厂（SMF）是美敦力在华独资的***家生产企业，成立于2006年11月，于2007年4月正式启用。公司坐落于漕河泾高科技园区，总投资4000万美金，总建筑面积达18，414平方米。其中10万级洁净车间面积为3000平方米，实验室总面积为500平方米。公司员工总数近340名，现生产产品16个品种，包括心脏瓣膜、医用高频仪器设备，腹部外科手术器械，手术室、急救室、诊疗设备及器具。
Medtronic Shanghai Manufacturing Facility (SMF) is Medtronic’s first wholly-owned manufacturing subsidiary in China. The site was founded in November 2006 and officially inaugurated in April 2007. With an initial investment of 40 million USD, SMF boasts a gross floor area of 18,414 square meters in Caohejing Hi-Tech Park. The site is composed of 3,000 square meters with Class-8 clean room and 500 square meters for laboratory use. There are currently 340 employees and 16 product lines producing
tissue heart valves, high-frequency medical equipment, abdominal surgery instruments, and diagnostic/treatment instruments used in the operation room and first aid.

公司每年平均引入1-2种新产品投入生产。2014-2015年与美敦力中国研发联手，成功推出基于微波消融技术的肝癌手术设备和新一代血管闭合与组织融合先进电外科设备。2016年公司更以1300万美元的投资额引入美敦力全球***的事业部-心脏业务集团的心脏瓣膜项目，以造福先天性心脏病、风湿性心脏病、冠心病、
心律失常或瓣膜退化、以及心脏血管病变等患者。2017年公司开始正式生产心脏瓣膜产品，预计每年将能够帮助中国和全球的65000名患者更及时地获得高品质的治疗。
SMF continuously expands its local manufacturing capabilities by adding one or two new products to its portfolio per year in average. In 2014 through 2015, collaboration between SMF and Medtronic China Technical Center successfully drove launches of the ablation technology based hepatic surgery devices and new generation of advanced electrosurgical instruments for vessel sealing and dividing. In 2016, 13 million USD was invested in SMF’s further evolvement to introduce the new tissue heart valve manufacturing line for the Medtronic Cardiac Vascular Group. The tissue heart valve material will contribute to helping patients who suffer from congenital, cardiovascular, coronary and rheumatic heart diseases. Starting 2017, the combination of our local and global heart valve manufacturing will help 65,000 patients improve their access to high-quality treatment in China and around the world.

美敦力上海工厂(SMF)致力于成为全球共享制造基地及区域性业务战略伙伴，提供世界一流品质的产品和服务，坚持人才培养，实现员工价值。
The Medtronic Shanghai Manufacturing Facility (SMF) is dedicated to becoming the global shared manufacturing site and regional business strategic partner that provides world class quality products and services, investing in talent development and realizing individual value for our employees.