Join BD as an Expert Assurance de Stérilité on a 12-month fixed-term contract (CDD) located in Le Pont-de-Claix Cedex, France. In this role, you will define and maintain sterility assurance strategies, manage validation processes, ensure rigorous regulatory compliance, and collaborate with cross-functional teams to advance the world of health.
Requirements
Engineering degree or Master's degree in microbiology, biotechnology, pharmacy, or a related scientific discipline.
Minimum of 5 years of relevant sterility assurance experience in the medical device or pharmaceutical industry.
Strong knowledge of sterilization methods like EO and irradiation, plus standards such as ISO 11135, ISO 11137, ISO 11737, GMP, and FDA regulations.
Intermediate English language proficiency.
Skills & Responsibilities
Sterilization validation: Manage and supervise validations and periodic revalidations for ethylene oxide, irradiation, and steam sterilization.
Regulatory compliance & audits: Ensure adherence to ISO, GMP, and FDA standards while participating in internal and external audits.
CAPA & non-conformance: Lead investigations into sterility-related non-conformities and implement effective corrective and preventive actions.
Technical documentation: Draft and review standard operating procedures, technical documentation, and release sterile product batches.
Potential transition routes: People from Quality Assurance, Validation Engineer, or Microbiologist roles may bring relevant compliance and laboratory skills, alongside meeting the required industrial experience and scientific degree.
Job description
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
Responsabilités principales :
Définir, mettre en œuvre et maintenir les stratégies d'assurance de stérilité pour les produits BD.
Assurer la conformité aux réglementations nationales et internationales (ISO, BPF, FDA) en matière de stérilisation.
Gérer et superviser les validations de stérilisation (stérilisation à l'oxyde d'éthylène, irradiation, vapeur, etc.) et les revalidations périodiques.
Évaluer les changements de processus, de matériaux ou de conception de produits ayant un impact sur la stérilité.
Participer aux audits internes et externes relatifs à l'assurance de stérilité.
Rédiger et réviser la documentation technique, les procédures opératoires standard (SOP) et les protocoles de validation.
Mener des investigations sur les non-conformités liées à la stérilité et proposer des actions correctives et préventives (CAPA).
Collaborer avec les équipes de R&D, production, qualité et affaires réglementaires.
Assurer une veille technologique et réglementaire continue dans le domaine de la stérilisation.
Participer à la libérer les lots stériles (revue de dossier de stérilisation).
Former et sensibiliser le personnel aux bonnes pratiques.
Profil recherché:
Diplôme d'ingénieur ou Master en microbiologie, biotechnologie, pharmacie ou un domaine scientifique équivalent.
Minimum 5 ans d'expérience significative en assurance de stérilité dans l'industrie des dispositifs médicaux ou pharmaceutique.
Excellente connaissance des méthodes de stérilisation (EO, irradiation) et des exigences réglementaires applicables (ISO 11135, ISO 11137, ISO 11737, BPF, FDA 21 CFR Part 820 et ISO13485).
Maîtrise des outils statistiques pour l'analyse des données de stérilisation.
Expérience en gestion de projet et en résolution de problèmes.
Capacité à travailler de manière autonome et en équipe dans un environnement matriciel.
Anglais intermédiaire
Fourchette de rémunération pour le poste : 45 000 à 50 000 EUR
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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Primary Work Location
FRA Le Pont-de-Claix Cedex
Additional Locations
Work Shift
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
