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. 

Duties and Responsibilities:

• Analyzes and solves manufacturing process problems under the mentorship of a senior Bioprocess Scientist. May support Manufacturing and Quality Control investigations

• Collects and analyzes experimental data as required. Draw conclusions and generate experiment report

• Participates in the documentation and implementation of reagent manufacturing methods and processes

• Work in new product transfer or sustaining/manufacturing projects

• Prepares and submits SOPs, BOM (Bill of Material), routings for new products

• Support senior Bioprocess Scientists to analyze and tackle problems in Production and Quality Control

• Provides technical and project management support to Manufacturing and Quality Control Supervisors on projects

• Evaluates technologies for reliability, reproducibility capability, consistency, and cost effectiveness

• Leads multiple, cross- functional and/or cross-departmental projects and initiatives

• Assists the validation department to develop validation protocols. Ensures validation of equipment and processes, evaluates data, and writes reports

• Develops experimental test methods and protocols

• Evaluates and investigates production process failures through Non-Conformance Reports, Corrective and Preventive Action Reports and generates deviation reports where required

• Maintains technical communication between the BDB manufacturing sites of Cayey, and other BD plants technical and development groups

• Formulate sampling procedures and evaluates data using statistical tools

• Performs Continuous Improvement tasks: Supports in the preparation of value stream maps, monitoring predicted savings in CI Projects and promoting identification of opportunities to reduce all forms of waste

• Lead and/or participate in blitzes and projects as required

• Promotes a safe work environment. Provides recommendations on maintaining the safety of the work environment.  Follow safety procedures.  Participates in Environment Health and Safety (EH&S) programs. Initiates a corrective action whenever a hazard is identified.  Notifies supervisor of all observed hazardous conditions or unsafe work practices

• Stays on top of the basic requirements for compliance in your own area of work and stays in sync with those requirements.  Participates as required in training on regulatory issues affecting their own area of work.  Brings regulatory compliance questions/issues to next level of management

• Actively participate in the Daily Management System by attending, leading shift start up meetings, and providing appropriate metrics

• Performs audits to SSU (Shift Start up Meeting) meetings and PVD (Primary Visual Display) Boards

• Actively attend and participate in the ESC (Executive Steering Committee) meetings and initiatives

• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability

• Performs other related duties and assignments as required

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Knowledge/Skills:

• Knowledge in Biotechnology manufacturing and testing. 

• Strong statistical analysis knowledge.

• Experience managing projects

• Effective skills on analytical thinking, problem solving, interpersonal relationships, written and oral communication, planning/organization, and project management skills

• Demonstrated ability to follow established policies and procedures

• Knowledge of GMP and OSHA requirements

• Fluent in English and Spanish languages (written, read and oral)

• Experience on MS Windows software such as MS Office

• Willing to travel to US mainland and offshore if required

• Apply principles of logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions

• Manage stressful situations

Education and Experience:

• Requires a minimum of a Bachelor of Sciences in a related scientific field such as Engineering, Chemistry, Biochemistry or Biology

• Experience in Process Investigation

• A minimum of five (5) years of experience in a Manufacturing or QC laboratory environments