Integra LifeSciences Senior Microbiologist/Sterilization in CN, China
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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.
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.
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。
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。
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
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。
TOOLS AND EQUIPMENT USED 工具和设备使用
General office equipment: computers, printers, copiers, telephone communications equipment.
PHYSICAL REQUIREMENTS 身体要求
Good health, no occupational taboo and infectious diseases
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.