Job Description Summary

This position ensures product safety, product quality, and compliance with all relevant global regulations and customer expectations. Additionally, it drives the implementation and sustainability of the sterility assurance (sterilization and contamination control) programs for the ID/AST, 250 Media and DCM plants. This position will have supervisory responsibility over a group of Quality Engineers that support sterilization and validation.

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. 

Job Summary:

The Staff QE, Sterilization, Validation Site Lead is responsible for contribution to the definition of the strategy and tactics required to achieve site/business unit/business line objectives for both Sterilization and Validation. 

Responsibilities:

• Sterility Assurance Champion: Lead our comprehensive site sterility assurance program across multiple sterilization modalities (ethylene oxide, radiation, moist heat, dry heat, and aseptic processing). Interpret ISO standards and translate corporate policies into actionable local procedures.
• Strategic Prioritization: Drive key site sterilization initiatives, validation projects, and supplier management objectives with a focus on continuous improvement and innovation.
• Quality Leadership: Provide expert recommendations to align site sterilization and microbiology capabilities with segment strategy, ensuring our validation team is properly resourced to meet regulatory requirements.
• Validation Excellence: Develop and maintain the site-level Validation Master Plan, establishing the foundation for all validation activities.
• Cross-Functional Collaboration: Build influential relationships with leadership team members to identify quality improvement opportunities and implement new processes that optimize efficiency.
• Problem-Solving Catalyst: Foster an environment of critical thinking, innovation, and rapid issue resolution to address complex sterility challenges.
• Project Leadership: Spearhead special projects aligned with team goals to meet microbiological, sterilization, and supplier management strategic priorities.
• Supplier Management: Guide strategic sourcing/procurement teams in qualifying and managing contract sterilization and testing suppliers.
• Technical Expertise: Serve as the site's sterilization subject matter expert for process development, manufacturing environment design, test failure investigations, and audit responses.
• Metrics & Monitoring: Establish robust systems to track, report, and monitor sterility assurance and validation metrics, providing proactive recommendations for addressing negative trends.
• Quality Advocacy: Manage customer-impacting issues with a commitment to upholding the highest quality and compliance standards.
• Regulatory Knowledge: Apply working knowledge of FDA medical device regulations and international quality standards (21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).
• Best Practice Sharing: Act as segment liaison among plants, businesses, and functions to communicate metrics, best practices, and successful technology advances.
• Inspirational Leadership: Lead by example as a recognized subject matter expert in validation and sterility assurance.
• Team Development: Mentor and develop personnel with dedicated succession planning and contingency management.
• Knowledge Transfer: Train site/business unit members on sterility assurance principles and practices.
• Industry Engagement: Participate in external technical associations (ISO, ASTM) related to sterilization, microbiology, and contamination control.
• Audit Support: Provide expert guidance during sterility assurance and technical audits.
• Team Leadership: Lead and inspire a talented team of sterility assurance and validation quality engineers.

Required Qualifications:

• Bachelor's degree in Engineering, Microbiology, Biology, Medical, Technology or life science.

• 6 years of experience in sterilization, microbiological and/or supplier management in medical device and/or healthcare industry.

• Demonstrated experience in handling and gaining consensus across cross functional teams within sites.

Preferred Qualifications:

• Industry Recognized certification in a Quality System Element specialty (e.g ASQ Certified Quality Auditor, Quality Manager, Quality Engineer)

• Experience or training with Six Sigma methodology and project management techniques

• Related Standards Management experience (ISO, ASTM…)

• Auditing experience and certification as a technical auditor

Skills and Knowledge:

• Ability to liaison with regulatory agencies as required.
• Knowledge of cGMP’s, Pharmacopeias (USP, EP…), Standards (ISO, EN…) and regulations (FDA, NMPA, EU…) with regards to laboratory practices, process environments, sterilization methods, ethylene oxide residuals, and bacterial endotoxin.
• Versed with ISO sterilization/sterility assurance standards for radiation (ISO 11137), moist heat (ISO 17665), ethylene oxide (ISO 11135), dry heat (ISO 20857), cleanrooms (ISO 14644) and aseptic processing (ISO 13408)
• Possesses effective communication and technical writing skill.
• Ability to work effectively with all levels of BD associates and to work through others to accomplish the goals supporting the overall business objectives.
• Previous performance record demonstrating initiative, strong organizational and motivational skill set, effective customer interaction, strong decision-making skills, able to lead and influence others and ability to work within a team environment.

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.

Required Skills

Optional Skills

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Primary Work Location

USA MD - Hunt Valley

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$113,400.00 - $186,900.00 USD Annual