BD (Becton, Dickinson and Company) 高级质量控制工程师(微生物)_Quality_SZP2_苏州 in Suzhou Plant 2, China

Job Description Summary

Engage in microbiology monitoring activities within the plant to meet quality, service level, cost and business objectives.


Job Description

  • Responsibility of the incumbent to perform all tasks in a safe manner, keeping in mind safety awareness at all times. It is expected that the incumbent will not only practice safety on the job, but will be responsible for the safety of others working in the area.确保自己不管是在工作中还是工作外,对自己还是他人,任何时候都具有安全意识。

  • Familiar with CP, USP, EP and CGMP regulation. Develop water system and environmental testing strategy. Lead QC microbiology team to implement and complete the tasks on Purified Water, WFI and Clean Room monitoring, raw material and products inspection, material change projects and relative validation.熟悉中国药典,USP,EP和CGMP等规范,制定水系统和环境检测策略,领导QC 微生物团队实施并完成纯化水和注射用水的监测,洁净室监控,产品检验及物料变更等微生物监测工作。

  • Develop method validation for microbial related and lead QC microbiology team to implement.制定微生物相关方法验证方案并领导QC微生物团队实施。

  • Work on microbiology relative tasks in conjunction with Manufacturing, Reagent,materials and Engineering counterparts on new product introduction, material change projects.分别与生产部,试剂部,物料部和工程部合作,负责新产品引入,物料变更等相关微生物工作。 ● Take responsible for related data trending analysis.负责相关数据的汇总分析。

  • Lead or participate in assigned projects and/or tasks to promote efficiency, verification and implementation of solutions and control processing to achieve product and process conformance.参与或领导分配的项目,以提高方案的效率,有助于生产工艺的实施。

  • Provide technical guidance to other personnel and assigned teams; mentor others in the organization.领导团队并为成员提供技术指导。 ● Perform any other task(s) as assigned, or defined in related quality procedure. 完成其他安排的工作,或相关质量程序中定义的工作。 Education 教育

  • Bachelor degree or above degree in Biochemistry, Biology, Medicine, or related science with minimum of 5 years of microbiology experience.本科或以上学历,生物化学,生物,医学等相关专业,至少5年微生物相关工作经验。

  • Familiar with ISO 13485 ,GMP and CP熟悉ISO 13485,GMP规范,中国药典

  • Familiar with QC tool, CI tool, Project Management and Validation.熟悉QC工具,持续改善工具,项目管理和验证。

Primary Work Location

CHN Suzhou Plant 2

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.