Expert Sterility Assurance

Responsibilities

• Define, implement, and maintain sterility assurance strategies for BD products.
• Manage and supervise sterilization validations (EO, irradiation, steam, etc.) and periodic revalidations.
• Ensure compliance with national and international regulations including ISO, BPF, and FDA.
• Lead investigations into non-conformities related to sterility and implement CAPAs.
• Perform risk analyses for processes and methods.
• Review sterile batch records for product release.
• Act as a technical referent during client audits.
• Collaborate with R&D, production, quality, and regulatory affairs teams.

Requirements

• Engineer or Master's degree in microbiology, biotechnology, pharmacy, or an equivalent scientific field.
• Minimum 5 years of significant experience in sterility assurance within the medical device or pharmaceutical industry.
• Deep knowledge of sterilization methods (EO, irradiation) and regulatory standards (ISO 11135, ISO 11137, ISO 11737, BPF, FDA 21 CFR Part 820, and ISO 13485).
• Proficiency in statistical tools for sterilization data analysis.
• Fluency in both French and English (written and oral).
• Proficiency with SAP and Trackwise.
• Strong organizational skills, rigor, and attention to detail.

About the Company

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.