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BD (Becton, Dickinson and Company) BioProcess Engineer II in San Jose, California

Job Description Summary

Represents reagent operations as a core team member in new product teams responsible for the development, scale up, validation and transfer of production processes to Operations. With minimal guidance, works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Works with cross functional teams and exercises judgment in determining the scope and timing of transfer activities. Responsible for improving process efficiency and product quality. May determine methods and procedures on new assignments, and may provide guidance to other lower level associates.

Job Description

Excited to grow your career?

We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!

Our people make all the difference in our success.

May participate in new product core teams as the reagent operations core team member. May be responsible for the successful transfer of products and processes into manufacturing following the Glob

Excited to grow your career?

We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!

Our people make all the difference!

  • May participate in new product core teams as the reagent operations core team mer

  • Maybe responsible for the successful transfer of products and processes into manufacturing following the Global Product Development System.

  • Develop, scale up and set up the manufacturing processes.

  • Generates manufacturing plan based on the product requirements and the anticipated manufacturing resources needed to produce and ship the new product.

  • Prepares and submits SOP’s, WI’s, BOM’s, routings and standard costing for new product into SAP

  • May provide floor support, evaluate product history, recommend revisions to product specifications, originate Change Orders (CO's)

  • Analyzes and solves problems in Production and Quality Control.

  • Responsible for root cause analysis for product complaints through experiments involving flow cytometry/applications and production process evaluations including physical property or analytical data analysis.

  • Responsible for the timely documentation of the results and conclusions.

  • Works with the team to apply Lean and Six Sigma practices into the development, scale up and setup of the manufacturing processes.

  • Responsible for working with the team to design, write and execute Gage R&R, scale up, stability, and validation studies and associated reports.

  • With support from functional manager, interfaces with Product Development, Research, Quality, Regulatory and Production to bring new technologies, methods, and tests into Manufacturing Assists in the evaluation of technologies and processes for reliability, production capability, consistency, and cost effectiveness.

  • Makes recommendations for process improvements. Trains Chemists/Technicians in processes and procedures

  • Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements.

  • Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management Promotes a safe work environment.

  • May provide recommendations on maintaining the safety of the work environment.

  • Participates in Environmental Health and Safety programs.

  • Addresses corrective actions whenever a hazard is identified.

  • Notifies supervisor of all observed hazardous conditions or unsafe work practices

Education and Experience:

  • Requires a minimum of a Bachelor’s degree in biological sciences with 5 years of relevant experience or Master’s degree with minimum of 3 years of relevant experience.

  • A minimum of 3 year experience in a FDA or ISO regulated production environment.

Assets

  • Project management experience

  • Knowledge in antibody techniques, molecular biology techniques, instrumentation, and assays performed

  • Knowledge of general laboratory safety, GMP's and associated regulatory requirements

  • Experience in statistical analysis, 6 Sigma Greenbelt or Lean Manufacturing certification preferred.

  • Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.

  • Experience with SAP

At BD Becton, Dickinson & Co., you are one person making one big difference. You are a key member of a team that is an important part of a leading, purposeful company committed to advancing the world of health. No matter what role you play, you can be confident that you are improving lives, all over the world. And, as you progress with us, your impact will only grow.

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.

Primary Work Location

USA CA - San Jose (Reagents)

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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