Bead Manufacturing Engineer III at BD
San Diego, CA 92101
About the Job
Bead Manufacturing Engineer III
Job Description Summary
In-depth knowledge of product development, extensive experience in scale up, process improvements, validation and transfer of production processes to Operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment in determining the scope and timing of transfer activities. Exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.Responsible for improving process efficiency and product quality. Determines methods and procedures on new assignments, and provides guidance to other lower level associates.
Job Description
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
In-depth knowledge of product development, extensive experience in scale up, process improvements, validation and transfer of production processes to Operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment in determining the scope and timing of transfer activities. Exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
Responsible for improving process efficiency and product quality. Determines methods and procedures on new assignments, and provides guidance to other lower level associates.
DUTIES AND RESPONSIBILITIES
Represents Reagent operations in new product teams as the core team member. With minimal supervision and assistance, transfers products and processes into manufacturing following the Global Product Development System
Develops strategies and executes plans to stabilize and reduce production cost of new products
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
Involved in providing floor support
Independently performing 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.
Evaluates failures, writes Variance Reports (VR's), presents recommendations to Material Review Board
Analyzes and solves complex and challenging problems in Production and Quality Control.
Provides support by providing flow cytometry expertise to experimental strategy, problem characterization, data acquisition and analysis.
Evaluates product history, recommends revisions to product specifications, originates Change Orders (CO's)
Extensive knowledge in product lines or manufacturing processes.
Identifies areas for improvements in product quality, process capability and production costs.
Applies Lean and Six Sigma practices into the development, scale up and setup of the manufacturing processes.
Responsible for the design, writing and execution of Gage R&R, scale up, stability, and validation studies.
Design, Write and Execute all development activities and reports, validation protocols for manufacturing equipment and processes.
Ensures validation of equipment and processes, evaluates data and writes reports. With minimal support, in
Interfaces with Product Development, Research, Quality, Regulatory and Production to bring new technologies, methods, and tests into Manufacturing.
Evaluates technologies and processes for reliability, production capability, consistency, and cost effectiveness.
Makes recommendations for process improvements.
Assists and mentors fellow associates to develop skills and techniques.
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
MINIMUM QUALIFICATIONS
Education and Experience:
Requires a minimum of a Bachelor degree with 7 years of experience or a Master’s degree with 5 years of experience or PhD with 2 years of Industry experience in biological sciences or related field
A minimum of 6 years of experience in FDA or ISO regulated production environment
Preferred - A minimum of 1 years of experience in managing a large or complex project
Experience in statistical analysis, Six Sigma
Technical expertise in molecular biology/antibody techniques, instrumentation, and assays performed
Preferred - Project management experience
Experience in SAP/ related Enterprise management system.
Assets
PMP Certification
Six Sigma Black Belt/ Lean Certification
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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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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