1.Principal Accountabilities (Major end results the job is expected to achieve)

主要工作职责（主要工作成就，期望此职位达到的目标）

1)Perform routine micro testing, e.g. bioburden, sterility test etc., and deliver report in time

进行常规的微生物测试，例如：生物负载、无菌测试等，并及时出具报告

2)Perform CA, PW and environmental monitoring and other process including culture/media preparation

压缩空气、纯化水和环境监测以及菌种/培养基制备等其他日常工作

3)Review data obtained for compliance to specifications and report abnormalities

审核获得的数据是否符合质量标准以及报告的异常性

4)Troubleshoot microbiological OOS occurrences and support change controls, CAPAs and investigations

解决微生物OOS问题及协助变更控制，CAPAs和调查

5)Plan, write, perform and follow method validation, equipment qualification, cleaning validation and sterilization validation protocols/reports

计划、编写、执行和跟踪方法验证、设备确认、清洁验证和灭菌验证相关方案/报告

6)Perform required calibration/maintenance on microbiological equipment

对微生物设备执行所要求的校验/维护

7)Ensure safe working in accordance with cGMP/HSE guideline at all time

始终按照cGMP/HSE规范确保安全工作

8)To review data and perform the data trend analysis, complete the related annual summary report

审核数据，并完成数据趋势分析，完成相关项目的年度总结报告

9)Other tasks assigned by the supervisor

主管分配的其他工作

2.Knowledge and Experience

资质和经验（此职位所要求的资质和经验）

1)Education-bachelor’s degree in Microbiology or related field

教育-微生物相关专业本科学历。

2)Experience- 3 years work experience in quality assurance/quality control lab and /or related field.

经验-在质量保证/质量控制实验室和/或相关领域3年以上经历。

3)Must have understanding of compendial requirements, ISO 13485/cGMP regulations and microbiological techniques.

必须了解法规， ISO 13485/cGMP法规和微生物技术。

4)Familiarity with validation activities, additional specialized training helpful (e.g. gamma sterilization or ETO sterilization)

熟悉验证活动、有额外的专业培训更好（如γ灭菌或ETO灭菌）

Desirable要求

1)Experience in the Medical/Pharmaceutical/Chemical industry 有在医疗/制药经验

2)Have little microbiology lab management 有部分微生物实验室管理工作经历

3)Experience of working in a foreign owned company 外企工作经验

上班地址：苏州工业园区苏虹中路200号综合保税区西区吴巷路12号

Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.

We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
? Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
? Advanced Wound Management - wound care treatment and prevention products used to treat hard to heal wounds
? Sports Medicine - minimally invasive surgery of the joint
? Trauma & Extremities - products that help repair broken bones

We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion.
We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN) .