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. 

Job Summary
The Quality Engineer, Validation will be responsible for ensuring the quality and compliance of Becton, Dickinson and Company's products and processes through the development, execution, and review of validation activities. This role plays a critical part in maintaining regulatory adherence and product reliability across various stages of the product lifecycle.

Job Responsibilities

• Develop, execute, and review validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, software, and test methods in accordance with company procedures and regulatory requirements (e.g., FDA, ISO).
• Perform risk assessments and develop validation strategies to ensure appropriate controls are in place and documented.
• Analyze validation data, generate comprehensive validation reports, and present findings to cross-functional teams.
• Collaborate with R&D, Manufacturing, Engineering, and Regulatory Affairs to define validation requirements and ensure successful implementation.
• Investigate and resolve deviations, non-conformances, and CAPAs related to validation activities.
• Participate in design reviews and provide input on validation considerations for new product development and changes to existing products.
• Maintain and update validation master plans and schedules.
• Support internal and external audits by providing validation documentation and subject matter expertise.
• Identify and implement continuous improvement opportunities within the validation process.
• Train and mentor junior engineers and technicians on validation principles and procedures.

Job Qualifications

• Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Chemical) or a related scientific discipline.
• Minimum of 3-5 years of experience in a Quality or Validation engineering role within a regulated industry, preferably medical devices or pharmaceuticals.
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and industry validation standards.
• Proven experience in developing, executing, and reviewing IQ, OQ, and PQ protocols and reports.
• Proficiency in statistical analysis and data interpretation related to validation.
• Excellent written and verbal communication skills with the ability to effectively present technical information.
• Strong problem-solving and analytical skills with attention to detail.
• Ability to work independently and as part of a cross-functional team in a fast-paced environment.
• Experience with risk management methodologies (e.g., FMEA) is highly desirable.
• ASQ certification (CQE, CQA, or CQV) is a plus.

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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