AddressJob Description Summary
This position will be responsible for the equipment, process, and dose mapping validations for the site, including individual product, shipper, and case carton dose map. This person will interact with manufacturing and the design centers to ensure that the sterilization process is validated in compliance with the product requirements and applicable industry standards. In charge of defining and maintaining the sterilization processing categories and the product families. In charge of precision dosing of products for routine dose audit requirements per internal policies and applicable industry standards.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
Develop and maintain Site Validation Master Plan
Develop validation protocols, submit for approval, approve, manage execution of validation activities, and draft final reports.
Support to implement the routine processing for all products on site including documenting and maintaining processing categories and product families.
Responsible for dose mapping activities for all new products, and all revised products per applicable change control, to be sterilized on site.
Support with daily activities of business support, technical or production.
Responsible for creation of control documentation such as WI, setup requirements etc.
Responsible for calibration compliance
Develop and maintain validation procedures and related local records.
Supports internal and external quality system audits including regulatory authorities, notified bodies and customers, as applicable.
Develop and maintain Validation Tracking Schedule (VTS)
Support and influence change management on site: Liaison between Validation Core Team, Unit Program Managers and Unit Validation Champions
Mentoring and/or training in technical elements of validation (such as Risk Analysis, MSA and DOE) and sterilization process (such as dose mapping, dosimeter placement, product-to-sterilizer orientation, etc).
Support site change control procedures
Participate in management review and Executive Steering Committee to report on Validation Status
Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
EXPERIENCE:
5+ years of combined Quality/ equipment / process validations experience preferred.
3+ years of experience in Sterilization Validations including dosemapping preferred.
3+ years of experience with medical device or other regulated industries preferred.
Familiar with sterilization concepts and standards.
Sterilization experience in e-beam preferred
Quality System Requirements experience
Process development experience
Knowledge of analytical and statistical tools
Green Belt / Black Belt on Six Sigma Training is a plus
COMPETENCIES:
Has experience, knowledge, and skills in planning, writing, executing and reporting validations.
Applies knowledge and skills to a wide range of standard and non-standard situations.
Works independently with minimal guidance.
Usually determines own work priorities.
Acts as a resource and mentor for colleagues with less experience
EDUCATION:
Bachelor's or Associate Degree in Engineering, Microbiology or Science field.
Others:
Minimal required supervision
Set priorities among multiple tasks
Demonstrate effective leadership
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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
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