BD (Becton, Dickinson and Company) Sterilization Engineer in Sandy, Utah
Job Description SummaryResponsibilities will include cycle development and validations in accordance with FDA and other regulatory requirements, routine support of daily operations of sterilization plant, process systems design, project management and capital equipment acquisition. Support Sandy Utah Sterilization operations and WW Sterilization projects. Occasional travel required.
1. Work with internal resources to develop equipment specifications, project schedules, contracts and purchasing documents.
2. Interface with equipment suppliers in acquisition of equipment. Ensure equipment is delivered within specification and on schedule.
3. Coordinate with the facilities department to design facilities and process equipment.
4. Interface with customer and support staff to insure equipment and building meet end user requirements.
5. Coordinate installation of equipment and equipment startup.
6. Coordinate validations including FAT, IQ, OQ, PQ in accordance with FDA and other regulatory standards.
7. Develop or optimize sterilization cycles with the intent of improving cycle times, reducing lead times, and sterilizing new products.
8. Assure compliance with Federal, State and local safety/environmental regulations. Assist in environmental testing and reporting.
9. Develop Task Documents and Standard Operating Procedures. Maintain document status.
10. Develop maintenance schedules and spare parts inventories.
11. Assist EHS and QA engineering in preparing regulatory agency submissions to OSHA, EPA, FDA and other governmental bodies as needed
12. Capable of learning the requirements for leading hazardous material response situations.
13. Train operations and maintenance personnel.
14. Assist with FDA and ISO audits.
15. Develop experiments, test methods, and reports.
16. Participate on Corporate Teams focused on sterilization process best practices as needed.
17. Represent BD on ANSI/AAMI/ISO committees as needed.
18. Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
19. Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
20. Other duties as assigned.
Minimum Education: Bachelor's Degree in engineering, Mechanical or Electrical Engineering preferred.
Minimum Experience: Five to ten (5-10) years’ experience in medical device or pharmaceutical manufacturing, or chemical processing industry. Experience with ethylene oxide sterilization installation/operation/maintenance, or other sterilization methods is preferred. Experience in FDA regulated environment. Air pollution control systems installation/operation/maintenance experience preferred.
Primary Work LocationUSA UT - Sandy
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