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.

• Serve as a resource to product development and manufacturing for overall validation support to all areas of the San Diego facilities including utility, equipment, and manufacturing systems.
• Responsible for leading validation planning, protocol development / execution and project closure activities such as VMP updates.
• Assist in the development of equipment requirement and specifications.
• Lead development of Process FMEAs.
• Lead development of validation plans.
• Coordinate validation activities.
• Execute Equipment Installation, Operational and Process Qualifications.
• Assist in the purchase of validation equipment and tools.
• Notify Production Focus Teams of any failures detected during validation execution.
• May be required to assist in the preparation of budget for validation resources.
• Ensure that safety standards are maintained in the course of performing duties.
• Lead in the implementation of continuous improvement activities.
• Participate in external and internal audits.
• May have some formal team leader responsibilities including management of contractors.
• Assist in training associates on validation SOPs, quality guidelines and processes.
• Support metrics to evaluate overall validation program effectiveness.
• Support the tech transfer of new manufacturing platforms into manufacturing, which could include site to site transfers, as needed.
• Provide validation leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation and risk management.
• Support product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Lead continuous improvement activities of validation processes and templates.
• Engage corporate validation partners to support global quality continuous improvement projects and site implementation.
• Lead CAPA’s related to validation processes

Qualifications: Position requires a Master’s degree in Engineering (any) or related field of study AND Two (2) years of experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master’s degree in Engineering (any) or a related field of study and Two (2) years of experience, the employer will also accept a Bachelor’s degree in Engineering (any) or related field of study AND Five (5) years of experience in the job offered or related occupation in which the required experience was gained. Must also have demonstrated experience with: Quality assurance field in a regulated environment; Medical device industry; Medical device regulations (FDA 21CFR80.820, ISO13485, or ISO14971); At least 2 of these standards: 21CFR part 820 (QSR), ISO13485, ISO14971, ISO/TR 24971:2020, IEC 60601-1, IEC 62304, IEC 62366-1, or ISO 10993-1; and Owning and completing a CAPA successfully.

Salary offered for the position is $123,115.00 to $159,300.00/year

Primary Work Location: 10020 Pacific Mesa Blvd, San Diego, CA 92121

Additional Locations:
N/A

Work Shift:
Not Specified

To apply mail resume to Becton, Dickinson and Company, Attn: BDHR-DT, 3750 Torrey View Ct, San Diego, CA 92130, OR submit a resume to www.caljobs.ca.gov, OR submit a resume to https://bdx.wd1.myworkdayjobs.com/en-US/EXTERNAL_CAREER_SITE_USA. Must reference Job Title & Job Code: R-494518. EOE.

#DNPBD

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