Charge d'etudes RetD (H/F/D), Molsheim

Merck - avec plus de 300 ans de progrès et plus de 38000 employés dans le monde, se positionne en leader sur le marché Pharmaceutique, Chimique, et des Sciences de la vie. Avec passion, engagement et innovation, nous poursuivons un objectif commun : améliorer la qualité de vie. C'est pourquoi nous avons besoin de vous!

Your role

• The BioMonitoring Research and Development organization develops solutions for our customers: microbiology quality control laboratories in the pharmaceutical and food industry. 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: Pharmacopoeias (sterility test, bioburden control, environmental control, pyrogens, mycoplasmas ...), Good practices (laboratory, production), ISO standards. You understand and are willing to develop solutions for modern laboratories, including automation, sustainability and lab digitalization.
• In the project team, 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. You write the Validation Master Plan (VMP) in collaboration with Quality Assurance. Ultimately, you guarantee compliance with regulations and specifications. You develop validation summaries and guides for the end user to enable him to implement and validate our applications in his laboratory.
• 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. You contribute to the efficient functioning of our laboratories.

Profile

• Master of science or engineer degree in the life science field, you have a real interest for microbiology. You understand the science behind modern microbiology methods: molecular biology, cytometry, ATP detection…
• First experience in validation in an industrial environment.
• 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 innovative and modern solutions for microbiology laboratories.
• You are conformable working within a team in project mode, in a complex and multidisciplinary technical activity.
• Quality Knowledge: Pharmacopeias and/or ISO standard in the field of industrial microbiology, basic understanding in GMP, GLP. Statistics for data analysis.