Sterilization Engineer

BD (Becton, Dickinson and Company)•Tucson, AZ

53d•Onsite

About The Position

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. Responsibilities: The primary focus of this role is direct engineering support for a new sterilization facility. The facility has sterilization equipment that is highly technical. The facility also features fully automated material handling systems. The role will identify needed improvements for the equipment, and work with plant resources including operators, technicians, and QA to implement those improvements. Directs personnel in the troubleshooting and maintenance of electrical and mechanical systems used in the production process. Support troubleshooting includes occasional nights and weekends as needed. Supports the plant manufacturing efforts for continuous improvement in the areas of safety, quality, production, and cost. Responsible for drafting protocols, test execution, and report generation for process and equipment qualification. Required to document all new designs or modifications per plant policies and procedures. This documentation includes validations, change control forms, work instructions, machine specifications, schematics, software revisions, spare parts, and maintenance schedules, protocols, reports as applicable. Ability to handle projects of moderate scope, requiring coordination between vendors, R&D, and plant manufacturing functions. Works within required safety and quality standards for the equipment. Recommends vendors for commercial items and materials needed for a project. Keeps abreast of e-beam related best practices in project management, engineering, and maintenance. Initiates changes to practices and procedures to support continuous improvement and ensure compliance with applicable regulations. Works closely with all relevant functions (e.g., Sterility Assurance, Quality, Regulatory, EHS&S, GRC, Supply Chain, Operations) to ensure compliance with global standards and applicable regulations (FDA, EPA, OSHA, DOT, FM Global, NRC, AAMI etc.). Support the assessment and documentation of risk and hazard analysis.

Requirements

3+ years of manufacturing experience, preferably with automated equipment.
3+ years of experience with medical device or other regulated industries preferred.
Bachelor's degree in engineering (preferred electrical or mechanical), science, or related degree.
Familiar with sterilization concepts and standards.
Process development experience
Knowledge of analytical and statistical tools

Nice To Haves

Experience with electron beam accelerators a plus.
Green Belt / Black Belt on Six Sigma Training is a plus

Responsibilities

Direct engineering support for a new sterilization facility.
Identify needed improvements for the equipment, and work with plant resources including operators, technicians, and QA to implement those improvements.
Directs personnel in the troubleshooting and maintenance of electrical and mechanical systems used in the production process.
Supports the plant manufacturing efforts for continuous improvement in the areas of safety, quality, production, and cost.
Responsible for drafting protocols, test execution, and report generation for process and equipment qualification.
Required to document all new designs or modifications per plant policies and procedures.
Ability to handle projects of moderate scope, requiring coordination between vendors, R&D, and plant manufacturing functions.
Works within required safety and quality standards for the equipment.
Recommends vendors for commercial items and materials needed for a project.
Keeps abreast of e-beam related best practices in project management, engineering, and maintenance.
Initiates changes to practices and procedures to support continuous improvement and ensure compliance with applicable regulations.
Works closely with all relevant functions to ensure compliance with global standards and applicable regulations.
Support the assessment and documentation of risk and hazard analysis.