Staff microbiologist

Work Flexibility: Hybrid

Microbiologiste Staff (H/F)

La mission principale estde garantir que les produits Stryker sont propres et stériles conformément aux exigences réglementaires et aux normes des dispositifs médicaux,le/laMicrobiologiste Staff supervisera et veillera à ce que la propreté et la stérilité soient maintenues lors des tests, du suivi et de la validation des processus de nettoyage et de stérilisation, ainsi que dans les installations de fabrication associées. Il/ellesuperviseraet fournira des orientations techniques dans divers domaines d'expertise au sein et en dehors de l'équipe.Il/Elle Assurerala conformitédes produitsà toutes les réglementations et normes applicables.

Ce que vous ferez :

Vous travaillerezau sein de l'équipe d'Assurance Stérilité, sous supervision générale, la personne sera responsable de garantir des pratiques de stérilisation efficaces et efficientes, notamment mais sans s'y limiter :

1. Soutenir la maintenance de la classification et de la propreté des environnements contrôlés conformément aux normes applicables.
2. Surveiller les installations, y compris celles de production d’eau utilisées pour les processus de nettoyage.
3. Gérer la coordination des activités de suivi des processus sous la responsabilité de l'équipe d'Assurance Stérilité.
4. Analyser et contrôler les tendances des processus, notamment en lien avec les tests en laboratoire, le nettoyage et la stérilisation. Identifier en permanence les opportunités de stabilisation des tendances et utiliser les contrôles statistiques et autres outils pour repérer des opportunités d’économies.
5. Encadrer et former les membres de l'équipe et les groupes fonctionnels selon les besoins.
6. Participer à des initiatives mondiales et à des groupes d’experts inter-sites pour développer et harmoniser les pratiques de stérilisation et de laboratoire interne (y compris la planification, la gestion des consommables et des inventaires, ainsi que le maintien d’équipements et de processus qualifiés et validés).
7. Gérer les activités de validation et de requalification ainsi que les projets associés.
8. Mettre en œuvre et adapter les indicateurs liés aux processus et aux installations sous la responsabilité de l’équipe.
9. Maintenir des relations et soutenir les fournisseurs dont l'équipe d’Assurance Stérilité est responsable.
10. Agir en tant qu’expert mondial, partageant ses connaissances au sein de l'organisation Stryker à l’échelle mondiale.
11. Mettre en œuvre des initiatives d'amélioration continue.
12. Assurer la conformité à toutes les normes pertinentes.
13. Proposer des projets internes au responsable pour l’évaluation et la mise en œuvre de stratégies mondiales.

Ce dont vous avez besoin :

Exigé:

14. Diplôme en Microbiologie, Chimie, Biologie ou sciences connexes
15. Minimum de 4 ans d’expérience professionnelle dans l’industrie des dispositifs médicaux, pharmaceutique ou secteur similaire (secteur fortement réglementé en santé)
16. Maîtrise du français et de l’anglais
17. Connaissance pratique des normes réglementaires externes en surveillance environnementale / salles blanches, microbiologie / stérilisation, biocompatibilité du nettoyage, et tests en laboratoire tels que : EU MDR, GMP, normes ISO, EP.

Pré requis:

18. Expérience antérieure en laboratoire.
19. Connaissance des différentes modalités de stérilisation (ex. gamma, vapeur).

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Staff Microbiologist

Primarily responsible for ensuring that Stryker products are clean and sterile in accordance with regulatory requirements and medical device standards, the Staff Microbiologist will oversee and ensure that cleanliness and sterility are maintained during the testing, monitoring, and validation of the cleaning and sterilization processes, as well as in the associated manufacturing facilities. They will mentor and provide technical guidance across various areas of expertise within and outside the team. Ensuring compliance with all applicable regulations and standards.

What will you do:

Working within the Sterility Assurance team, under general supervision, the individual will be responsible for ensuring effective and efficient sterilization practices, including but not limited to:

20. Supporting the maintenance of classification and cleanliness of controlled environments in accordance with applicable standards.
21. Monitoring facilities, including water production facilities used for cleaning processes.
22. Managing the coordination of process monitoring activities under the responsibility of the Sterility Assurance team.
23. Analyzing and controlling process trends, especially related to lab testing, cleaning and sterilization. Continuously identifying opportunities to stabilize trends and utilizing statistical, and other process controls, to identify cost-saving opportunities.
24. Mentoring and training team members and functional groups as needed.
25. Participating in global initiatives and inter-site expert groups to develop and harmonize sterilization and internal laboratory practices (including planning, management of consumables and inventory, as well as maintaining qualified and validated equipment and process status).
26. Managing validation and requalification activities and related projects.
27. Implementing and adapting indicators related to processes and facilities under the team's responsibility.
28. Maintaining relationships with and supporting suppliers for which the Sterility Assurance team is responsible.
29. Acting as a global expert, sharing knowledge within the Stryker organization worldwide.
30. Implementing continuous improvement initiatives.
31. Ensuring compliance with all relevant standards.
32. Proposing internal projects to the manager for the evaluation and implementation of global strategies.

What you need:

Required:

33. Degree in Microbiology, Chemistry, Biology or related science
34. Minimum 4 years of applicable professional experience in in medical devices, pharmaceutical or related industry (highly regulated industry in healthcare)
35. Fluency in French and English
36. Working knowledge of external regulatory standards in environmental monitoring/cleanrooms, microbiology/sterilization, cleaning biocompatibility, and lab testing such as: EU MDR, GMP< ISO Standards, EP.

Preferred:

37. Prior experience working in a laboratory setting.
38. Knowledge of various sterilization modalities e.g. gamma, steam.

What we offer:

39. Flat hierarchies and responsibility. Through flat hierarchies, we strengthen the initiative and willingness of our employees to take over responsible tasks.
40. We grow talent. At Stryker we offer great personal and internal career development for our employees, with the possibility to make both vertical and lateral position movement.
41. Team spirit & engagement. We create engaged and inclusive teams that encourage colleagues to share their diverse perspectives and opinions.
42. Competitive salary and Benefits. With us, you will receive a competitive salary and benefits commensurate with your job.
43. Recognition of your performance. At our company, outstanding individual and cross-functional team performance is rewarded. Ideas, projects, or other exceptional achievements can be submitted for various awards on a local and global level.
44. Employee Resource Groups (ERGs). Our ERGs are dedicated to fostering an inclusive, diverse, and supportive workplace environment. They provide opportunities for development, networking, and collaboration, and are open to all employees. Our ERGs are committed to promoting inclusion and belonging, helping every individual thrive and contribute to our shared success.

Know someone at Stryker? Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at

Travel Percentage: None