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Principal Microbiologist - Merrimack, NH

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Date: Nov 23, 2021

Location: Merrimack, NH, US

Company: Getinge

 

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. A career at Getinge provides career opportunities that both inspire and challenge. Here, you can make a difference every day.

 

 

Job Overview

This position provides an opportunity for career growth while ensuring the quality, safety, and sterility assurance of cardiovascular medical devices and accessory products.

 

The position will provide a technical resource to lead or support projects relating to Sterilization, Microbiology, and Cleanroom Operations.   The Principal Microbiologist will facilitate the implementation of company policy and strategies with respect to product cleanliness, sterilization, and cleanroom operations. Additionally, he/she will support new product development, collaborating with Product Development Teams and suppliers to provide design inputs for microbiological quality and sterilization requirements. The position will support and drives validation activities for sterilization and cleaning processes and evaluate new technologies and test method changes related to sterilization and microbiology    He/she will be responsible for compliance to applicable Quality Regulations, ISO and AAMI standards.

 

Job Responsibilities and Essential Duties

  • Drive compliance of programs and procedures for microbiological activities (Sterilization, Environmental Controls). 
  • Monitor industry regulatory standards and guidance (AAMI/ ISO/ USP, EP, PDA,). Perform standard assessments as required and interpret requirements into site level programs. Represent Getinge in AAMI standard development committees.
  • Support EUMDR and FDA product submission activities.  Provide technical documentation and responses to notified bodies.
  • Develop and implement strategies to internalize Microbiological and Environmental Monitoring testing programs
  • Develop risk based approach methodologies to evaluate and continuously improve BET, bioburden, contamination control, and sterilization programs.
  • Provide a technical resource for evaluating alternate sterilization technologies, contamination control, and process monitoring. 
  • Develop and refine strategies and methodologies for microbiological testing, cleaning validations.
  • Collaborate with other Getinge sites to facilitate the harmonization of best practices and leveraging technologies across business units.
  • Support the Merrimack QMS improvement initiatives related to Sterilization and Clean room processes including Risk Management updates

 

Minimum Requirements

  • Minimum of Bachelor of Science in Biology, Microbiology, Chemistry or related field is required.
  • A minimum of seven (7) years or more experience managing microbiological studies in the medical device or pharmaceutical organization is required.

 

Required Knowledge, Skills and Abilities

  • Strong knowledge and experience in several of the following areas of competency:  terminal sterilization, aseptic processing, VHP decomaniation, clean room and contamination control, environmental monitoring microbiological methods and cleaning validation.
  • Experience with ISO class 8 clean room operational and qualification principles.  Experience with ISO class 5 clean room is preferred. 
  • Demonstrated working knowledge of current industry standards related to sterilization and microbiology such as:  11135, 10993-7, 11137, 17655,  11737 , ST72, 14698, 14644 , 17141.  Knowledge with biocompatibility 10993 series is a plus.
  • Expert knowledge and understanding of Microbiology principles, theories, concepts and laboratory methodologies.
  • Must demonstrate effective organizational skills and ability to manage multiple projects.
  • Must have demonstrated experience analyzing and interpreting technical results and summarizing these results in technical reports.

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Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

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We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.

 


Nearest Major Market: Manchester
Nearest Secondary Market: Nashua