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SUMMARY DESCRIPTION 工作简述

Qualified candidates must possess relevant experience as a Microbiologist in one or more of the following areas and be considered a Subject Matter Expert in a minimum of one area:

• Controlled environment monitoring

• Water system monitoring

• Bacterial endotoxin test method validation and monitoring

• Bioburden test method validation and monitoring

• Ethylene oxide sterilization validation and requalification management

Responsibilities associated with this position are directly associated to microbiological testing, monitoring, and sterility assurance used in medical device manufacturing. The candidate must have experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, implementing procedures, and remediation projects. Candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed above. The candidate must be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate. An understanding of clean room practice/GMP and laboratory/GLP environments is required. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment.

This position will be located in Suzhou.

合格的候选人必须在以下一个或多个领域拥有微生物学家的相关经验，并被认为是至少一个领域的主题专家:

• 受控环境监测

• 水系统监测

• 细菌内毒素检测方法的验证和监测

• 生物负荷测试方法的验证和监控

• 环氧乙烷灭菌验证和再确认管理

与该职位相关的职责与医疗器械制造中使用的微生物检测、监测和无菌保证直接相关。候选人必须具有解释和应用医疗器械微生物和无菌保证控制程序的标准和法规的经验，以解释数据，实施程序和补救项目。候选人必须具备足够的知识和经验，作为上述一个或多个领域的主题专家。应聘者必须具有团队合作精神，能在团队环境中茁壮成长，同时也有独立研究和调查的能力。了解洁净室操作/GMP和实验室/GLP环境。合格的候选人必须理解风险管理的概念，因为它涉及到医疗器械制造环境中的微生物监测和无菌保证。

该职位工作地点在苏州。

ESSENTIAL DUTIES AND RESPONSIBILITIES 岗位职责

To perform this job successfully, an individual must be able to perform each essential duty：

Generation and execution of microbial method validation protocols and reports including the writing, routing and approval of summary documentation.

Design experimental plans to address specific laboratory issues as needed.

Manage sample/testing processing with onsite and third-party labs, ensure timely testing and result reporting.

Ensure compliance of microbiology procedures, validations, and records with all company policies and procedures and appropriate regulations, including China GMP, FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11135, CMDR, Medical Device Directive, and USP.

Interpret microbiological data in order to identify trends and issues that require investigation.

Contribute to risk management activities including PFMEA generation.

Scheduling coordination, material allocation and alignment of personnel in order to successfully complete project assignments.

Create procedures for microbiological testing and sampling in alignment with validations and in compliance with application regulations.

Mentors non microbiology staff.

Serve as Microbiology representative on cross functional teams for transfer, NPI, and other projects as necessary including supervision of contract resources.

Experience with Controlled environment monitoring, Water system monitoring, compressed air monitoring, Bacterial endotoxin test method validation and monitoring, Bioburden test method validation and monitoring, and ethylene oxide sterilization validation and requalification management is preferred.

Ensure that all projects are in compliance with China GMP, cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

Support and address comments and suggestions associated with sterilization and microbiological test method validations and monitoring procedures.

Change control, non-conformance and CAPA support.

Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.

要成功地完成这项工作，个人必须能够履行每一项基本职责：

微生物方法验证方案和报告的生成和执行，包括总结文件的撰写、流转和批准。

根据需要设计实验计划以解决具体的实验室问题。

管理现场和第三方实验室的样品/测试过程，确保及时报告测试结果。

确保微生物程序、验证和记录符合所有公司政策、程序和适当的法规，包括China GMP，FDA和ISO 9001、ISO 13485、AAMI ST72、ISO 11737、ISO 14644、ISO 14698、ISO 11135、CMDR、医疗器械指令和USP。

解释微生物数据，以确定需要调查的趋势和问题。

参与风险管理活动，包括PFMEA的生成。

计划协调，材料分配和人员分配，以顺利完成项目任务。

创建微生物测试和取样程序，与验证一致，并符合应用法规。

培训和指导非微生物学人员。

在跨职能团队中担任微生物学代表，负责转移、新产品导入和其他必要的项目，包括监督合同资源。

有受控环境监测、水系统监测、压缩空气监测、细菌内毒素试验方法验证和监测、生物负荷试验方法验证和监测、环氧乙烷灭菌验证和再认证管理经验者优先。

确保所有项目符合中国GMP，cGMP, cGLP, QSR(包括设计控制)，ISO或其他适用要求。

支持和处理与灭菌和微生物测试方法验证和监控程序相关的意见和建议。

变更控制，不符合和CAPA支持。

参与FDA检查，ISO认证，监督审核和客户审核。

DESIRED MINIMUM QUALIFICATIONS zui

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Bachelor’s, or preferably Master of Science degree, in Microbiology or similar discipline.

4-7 years of experience in a microbiology-focused role for a medical device or pharmaceutical environment.

Demonstrates excellent organizational and communication skills.

Results-oriented with a strong focus on quality principles.

Excellent technical writing skills with an understanding of good documentation practice.

Experience conducting microbial test method validations and managing projects independently.

Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.

Working knowledge of applicable microbiology standards including, but not limited to, AAMI ST72, ISO 11737, ISO 14644, ISO 11135, and USP.

Ability to track milestones and manage projects.

Working knowledge of applicable regulations and their interpretation within industry.

Fluent Chinese and English

下面列出的要求代表了这个职位所需的知识、技能和/或能力。

微生物学或相关专业本科或硕士以上学历。

4-7年医疗器械或制药行业微生物相关工作经验。

优秀的组织和沟通能力。

以结果为导向，注重质量原则。

优秀的技术写作技巧，理解良好的文档实践。

有独立进行微生物测试方法验证和项目管理的经验。

具有环境和产品微生物监测操作规程的创建和变更经验。

具有适用微生物学标准的工作知识，包括但不限于AAMI ST72, ISO 11737, ISO 14644, ISO 11135和USP。

能够跟踪里程碑和管理项目。

具有行业内适用法规及其解释的工作知识。

流利的中英文。

TOOLS AND EQUIPMENT USED 工具和设备使用

General office equipment: computers, printers, copiers, telephone communications equipment.

一般办公设备:电脑、打印机、复印机、电话通讯设备。

PHYSICAL REQUIREMENTS 身体要求

Good health, no occupational taboo and infectious diseases

身体健康，没有职业禁忌及传染病等

DISCLAIMER 声 明

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

上面列出的职责仅作为可能执行的各种工作类型的说明，和工作职责类似但没有出现在上述列举的岗位职责中的工作，也应该包括在该岗位内。职位描述不构成雇主与雇员之间的雇佣协议，可以根据雇主的需要和工作变化的要求进行更改。