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Sterilization Quality Assurance Senior Specialist

In-Office, Le Pont-de-Claix, Auvergne-Rhône-Alpes

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ID da oferta
R-544315
Category
Operations
Location
Zelienople, ペンシルベニア州

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

The Sterilization Quality Assurance Specialist provides global quality and technical leadership for sterilization activities supporting new product development, lifecycle management, and special projects, including those managed by external partners. Reporting to the Global Operational Quality Director within BD – Biopharma Systems, this role is critical to ensuring patient safety, regulatory compliance, and successful product commercialization across a worldwide manufacturing network.

Main Responsibilities

  • Define and execute global sterilization strategies aligned with product design, materials, manufacturing processes, and regulatory requirements.
  • Provide quality and technical oversight for sterilization activities supporting new product development and design transfer.
  • Lead and support the development, validation, implementation, and transfer of sterilization processes.
  • Act as the quality representative for outsourced sterilization activities, ensuring supplier compliance and performance.
  • Review and approve sterilization validations, requalifications, and routine processing documentation.
  • Support internal and external manufacturing sites in routine sterility assurance and contamination control activities.
  • Define, harmonize, and continuously improve microbiology and sterilization testing methods across the Business Unit.
  • Support quality investigations related to microbiology, contamination control, and sterilization issues.
  • Contribute to risk management, change control, and continuous improvement initiatives.

Preferred profile

  • Degree in Microbiology, Engineering, or Pharmacy.
  • Minimum 5 years of experience in the industry within sterility assurance and contamination control.
  • Proven experience with sterilization processes (EO, gamma) and microbiological control.
  • Strong knowledge of regulatory and sterilization applicable standards (ISO 13485, ISO 11135, ISO 11 137, GMP)
  • Ability to operate effectively in a global, matrix organization with strong communication and collaboration skills.
  • Proactive, customer‑focused mindset with strong analytical and problem‑solving capabilities.

Salary range for the position : 55 000 to 65 000 EUR / year

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.

To learn more about BD visit https://bd.com/careers.

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.

Salary Range Information

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