Job Description Summary

Job Description

We are the makers of possible 

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. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Responsibilities

• Spearhead the implementation of comprehensive sterility assurance programs across multiple manufacturing sites within the region
• Develop and execute contamination control strategies aligned with industry best practices and regulatory requirement
• Manage all aspects of pre-market and post-market sterility assurance activities, including:
  • Production and process environmental control and compliance
  • Change control
  • Croduct release from sterilization
  • Sterilization validation compliance
  • New and modified product adoptions
  • Process improvements
  • Oversight of sterilization service suppliers (gamma, EO, E-beam technical audits and compliance to BD requirements)
  • Standardization initiatives (EO cycle optimization, cycle calculation validation approach).

• Establish key performance indicators to track compliance with sterility assurance requirements
• Conduct gap analyses across regional manufacturing sites to identify areas for improvement
• Identify potential quality risks related to sterility assurance and implement proactive mitigation strategies
• Provide expert guidance to manufacturing sites on:
  • Microbiological testing methodologies and laboratory controls
  • Environmental monitoring program design and data interpretation
  • Contamination control strategies for various product types
  • Sterilization process development and optimization

Required Qualifications

• Bachelor's Degree - Microbiology, Physical Science, Engineering, Math or related field.
• 5 years experience in sterilization or regulatory environment
• Experience with ISO, ANSI, AAMI sterilization standards, specifically Ethylene Oxide and Radiation
• Experience with Moist Heat and Dry Heat

Preferred Qualifications:

• Medical device or pharma experience preferred
• Experience with environmental and contamination control standards (i.e. Cleanrooms, biocontamination control)

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

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.

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