Sterilisation Expert Nogent le Rotrou Fr H/F - bbraun

You're an important part of our future. Hopefully, we're also a part of yours ! At B. Braun, we protect and improve the health of people worldwide. This is also our vision for research and development. You see complexity as an opportunity - and quality and sustainability are important criteria for your work. We would like to work with you on tomorrow's solutions. That's how we work to create sustainable healthcare - locally, in regions, countries and worldwide. Together. That's Sharing Expertise

You join Nogent-le-Rotrou B.Braun's plant, a medical devices manufacturer, with more than 500 people working in IT. The plant recently benefited from an extension to add more than 2300m² of clean rooms for production, and the building of a new sterilization chamber.Duties and responsibilities :
- BE responsible for coordination and organization of sterilization process validation (including re-validation activities) for EO and irradiation sterilization and the related products validation, supported by R&D and Quality Management departments for Nogent's plant and sub-contractors.
- Analyze process deviations and keep sterilization documentation updated for internal and external sterilization activities.
- Establish and maintain regular exchanges with global sterilization experts.
- Ensure Quality compliance for the sterilization process, identify and put in place preventive and corrective actions.
- BE the Subject Matter Expert during external audits or inspection performed by the certification bodies or the national competent authorities, for topics related to sterilization processes.
- BE the contact point regarding sterilization topics for the R&D department in its product development projects.
- BE responsible for the annual sterilization process review in cooperation with the Quality Director and other departments involved (Quality Control, Quality Management, Production, R&D).
- In a continuous improvement approach, propose and roll out improvements or modifications on Nogent's sterilization routine cycles Dans le cadre d'une démarche d'amélioration continue, proposer et mettre en place des améliorations ou modifications des cycles de stérilisation pour le site de Nogent-le-Rotrou.

Professional Competencies :
- You have an Engineer diploma and have experience on sterilization processes and on microbiologist topics. An experience in medical devices activities would BE appreciated.
- You have a minimum of 5 years experience on sterilization activities
- You have basic knowledge on microbiology
- Ideally, you know the norms ISO11135 :2014 and ISO11137 :2015
- You know project management tools
- You master problem solving methodology and tools
- You speak English fluently
- The mastery of French language would BE much appreciated

Personal competencies :
- You are known for your great rigor
- You have a quality-oriented approach
- You show great responsiveness
- You have demonstrated communication skills, and know how to adapt according the stakeholders
- You respect EHS rules on the plant.

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