Site Validation Leader
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
1. Lead the Validation Program as a Site Validation Leader. Responsible for the Local Implementation of Validation Toolkit.
2. Develop, maintain, and communicate the Validation Master Plan (VMP) and Validation Tracking Schedule (VTS).
3. Ensure validation support structure and document handling system are developed and maintained.
4. Host training and educational sessions appropriate for associates relevant to validation procedures. Establish mentoring process to improve effectiveness of validation work.
5. Establish and maintain systems that track Validation records ie: protocols, completion reports and total Validation Packages.
6. Support and influence change management at site: Liaison between Core Team, Unit Program Managers and Unit Validation Champions.
7. Develop and maintain validation procedures and related local records.
8. Approve protocols and reports as needed.
9. Develop and maintain metrics to measure progress.
10. Work with Corporate Validation Services to sustain validation activities.
11. Participate in regulatory audits and inspections as required.
12. If the SVL is also a Practitioner, use lean, problem solving methods, and data analysis tools and techniques in validation efforts.
13. Active member of the Validation Team. Participates in Management Review and Executive Steering Committee to report on Validation Status. Attending conference calls and regular meetings.
14. Develops and interacts in setting goals and use of improvement tools such as: Six Sigma, Lean and Validations
15. Provides technical support to Process Engineers in the development on validation strategies to
complete machinery and processes improvements and validations.
16. Develops Protocols, Engineering Studies, and Design of Experiment (DOE) as needed.
17. Prioritizing Validation, Validation Appraisals and direct contact with Regulatory Agencies and work with Corporate Validation Services to sustain validation activities.
18. Use of judgment and analysis of facts to determine action to be taken.
19. Meet Federal, State and Local Regulations and Corporate Policies.
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Education and Experience:
1. BS in Engineering or Science.
2. Minimum 3 years Process Validation Experience.
3. Six Sigma or CQE certification (Green Belt Level) preferred.
4. Strong technical, problem solving, and statistical background with process development experience.
Knowledge and Skills:
1. Effective communication skills.
2. Project Management skills.
3. Knowledge of Lean and Six Sigma for Manufacturing.
4. QSR/Manufacturing/Quality experience.
5. Excellent presentation and project management skills; Quality and detail oriented.
6. Leader, team player, makes things happen.
7. Should be willing to travel as needed.
8. Bilingual (Spanish & English).
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 PR - Anasco
Additional Locations
Work Shift
Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion