Validation Expert Microbiological Methods f/m

Posted 05 Sep 2022

Molsheim, Bas-Rhin - France

Req Id 255345

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


Your role:

 

The BioMonitoring Research and Development organization develops innovative solutions for our customers: microbiology quality control laboratories in the food and bev industry and pharmaceutics.

You are an important contributor to the development project teams, in charge of ensuring the validation of our solutions and methods in accordance with the requirements of our customers: ISO standards, FDA BAM, industry best practices and Pharmacopeias.

You understand and are willing to develop solutions for modern laboratories, including technology innovations, automation, connected instruments and lab digitalization.

In project teams, you define the validation strategy for the solution and its performance in its microbiological application. During development you participate in risk analyzes and contribute to design verification testing.

You organize and manage the documentation of validation work. To this end, you help define test plans and methods to characterize, verify and validate the performance of the product and its application.

Either internally or with external partner labs You write the Validation Master Plan (VMP). In case of an alternative method, you drive the certification study with the accreditation body (AFNOR VAL, Microval, AOAC…).

You define the validation protocol with the expert lab and lead the logistic aspects of the study (provide material and media) during performance comparison and interlaboratory study.

You contribute to the implementation of product quality documentation, in collaboration with production and subcontractors.

In the R&D validation team, you contribute to regulatory watch and the continuous improvement of validation practices and tools.

 

 

Who you are:

 

  • Master of science or engineer degree in the life science field, ideally in microbiology or food&bev science. You understand the science behind modern microbiology methods: molecular biology, cytometry, ATP detection…
  • Experience in the industrial microbiology in the field of food, beverages and water. A first experience in leading an ISO 16140 study would be beneficial.
  • Good level of English, written and oral. Ability to work in a multicultural organization.
  • Autonomous, rigorous, organized and good communication skills. As a member of an R&D organization, you are curious and eager to bring innovative solutions to our customers.
  • You are willing to work on lab digitalization and modern solutions, a first experience into the use of such tools would be a plus.
  • You are conformable working within a team in project mode, in a complex and multidisciplinary technical activity.

Quality Knowledge: ISO standard in the field of food and bev industrial microbiology, basic understanding in GMP. Statistics for data analysis. A first experience in US regulations would be a plus.


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
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Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

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