Job Description Summary

The Bioprocess Engineer Specialist in the Reagent MFG Sustaining Engineering group is an individual contributor that independently supports the Engineering processes and projects for BD Biosciences globally regarding reagent manufacturing sustaining efforts that occurs to maintain routine, roust and cost-effective manufacturing processes. This role works directly with site level functions driving cross business efforts to ensure all SKUs are routinely manufacturable according to customer and forecasted demand. The role reports to the Director, Reagent Mfg Sustaining Engineering and works closely with the Reagent Manufacturing Site Functional Leads and their respective Subject Matter Experts. This role also supports driving cross business efforts for new product introduction (NPI) and the implementation of cost-reduction, value engineering, and PPV efforts through sustaining engineering projects.

The Bioprocess Engineer Specialist will be expected to have a deep understanding of Research and Clinical product performance specifications, product QC test methods, project management methodologies, Root Cause Analysis, Value Stream Mapping and Continuous Improvement principles. He or she will drive for continuous improvement and agility supporting the sustaining process ensuring that project timelines and cost reduction goals are consistently met.

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. 

Descriptions Bioprocess Engineer Specialist, Reagent MFG Sustaining Engineering

The Bioprocess Engineer Specialist in the Reagent Mfg Sustaining Engineering group provides a technical leadership within multi-functional Sustaining Core team(s) and Project team(s) within a matrix and, FDA and ISO compliant organization, responsible for tackling multiple sustaining manufacturing engineering projects which heavily interface with site manufacturing, scientific/technical, quality and R&D teams.  The role will manage a high volume of projects by implementing a structured sustaining process and ensures timely completion.

The Bioprocess Engineer Specialist is accountable for leveraging new and diverse technical approaches resulting in optimized solutions by collaborating with quality, regulatory, manufacturing, and commercial in problem solving and decision making.

Job Responsibilities:

• Supply Chain Assurance
  • Provide support for new or replacement supplier selection, qualification and resolution of quality issues, including the definition of incorporation of critical feature inspection and test points in the manufacturing and QC process.
  • Support BDB reagent manufacturing processes required to meet long-term manufacturing output, efficiency, quality, and cost objectives.
  • Works with BDB Reagent Plant Managers world-wide to provide engineering support and systems to meet long-term production goals.
  • Leverages process and system uniformity across multiple manufacturing sites

• Sustaining Engineering
  • Participate on the Sustaining Engineering core team meetings, providing technical guidance and recommendations as it pertains to decisions on Sustaining Engineering Projects
  • Gather information, identify alternatives, analyze the cost/benefit, and select the best opportunities to execute
  • Drive CI/PPV/Re-design projects while working collaboratively with plant leadership, supply chain, quality, regulatory, R&D and business/platform leadership

• Engineering Leadership
  • Support identification and resolving gaps in key competencies, leadership, skillsets and succession depth to meet business need
  • Provide technical leadership in manufacturing sustaining engineering to provide technical product line support to ensure quality, delivery, and cost goals. Identify and drive implementation of continuous improvement projects such as, first pass yield, cycle time reduction, product reliability, customer complaints and cost reduction.
  • Maintain capital and financial budgets for assigned departments.

• Quality / Compliance
  • Maintain compliance with the Quality system
  • Maintain technical depth for problem resolution, manufacturing processes, lean manufacturing, and business processes (ECOs, MRB, CAPA and ERP applications)
  • Ensure safety program meets EH&S requirements.
  • Familiar with GMP’s, ISO requirements, the IVD Directive, CE marking, Six Sigma and LEAN principles.

Minimum Qualifications:

• Minimum twelve (12) years’ experience in product Manufacturing Sustaining Engineering in a regulated (ISO/IVD) regulated operation

Education and Experience:

• Bachelor’s Degree is required in Science/Engineering and post graduate degree (e.g. MBA or Masters or PhD) is preferred
• Black Belt or Design For Six Sigma and PMP are also preferred
• Track record of success in leading and managing complex, reagent sustaining engineering projects
• Experience in life sciences, biotechnology medical device or diagnostic industries
• Experience in managing projects to meet changing regulatory requirements is preferred
• Experience working in Design Control, Change Management, ISO and FDA environment
• Understanding of regulations, standards and guidelines related to IVD, and/or medical devices and quality systems including 21 CFR, IVDD, IVDR, ISO14971, ISO13485, etc.
• Experience managing external suppliers, vendors and contractors
• Effective verbal, written and presentation skills required.

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 CA - Milpitas 155

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

$114,500.00 - $189,100.00 USD Annual