BD (Becton, Dickinson and Company) Mechanical / Sterilization Engineer in Columbus, Nebraska
Job Description Summary
Essential Functions: Position requires ongoing support of terminal sterilization equipment and processes, along with responsibilities for future sterilization projects. Assist in process system design, capital equipment acquisition, installation and testing of equipment, commissioning of building systems, and validation of facility/process equipment. Assists with continuous improvement of facility systems and projects. This includes facility design, documentation, validation, and maintenance. Regular, punctual attendance is an essential job function. Ability to speak, read and write English. Ensures compliance with BD quality systems, policies, procedures and practices and all local, state, federal and BD safety regulations, policies and procedures.
1. Provides technical guidance as needed. Acts as a mentor and provides leadership for the technical sterilization team. Develops training programs for engineering related to sterilization processes and works directly with sterilization group to certify sterilizer operators.
2. Provide leadership and support for sterilization related projects designed to support the overall strategies of the plant. Lead the installation of new sterilization equipment including optimization of processes and compliance with all applicable regulatory standards
3. Maintains knowledge of developments in state-of-the-art sterilization processing technology.
4. Develop, write, and update process specifications and documentation for sterile pharmaceutical processing equipment including contracts, schedules and purchasing documents.
5. Works with sterilization group to develop protocols for qualification and validation of terminal sterilizing equipment, and routine re-certification of processes in place.
6. Interprets industry standards and regulations to ensure sterilization equipment performances within compliance. Ensures corporate sterilization policies and standards are applied and maintained.
7. Assist with facility process improvements, cost reductions, and manage projects while maintaining project budgets.
8. Coordinates plant shutdown activities for Sterilization operations.
9. Develop and maintain preventive maintenance schedules and spare parts inventories.
10. Ensures calibration of equipment.
11. Provide support to ongoing terminal sterilization operation as needed.
12. Other duties as assigned.
Annual respiratory fit test required
Minimum: Associate of Applied Science Degree : Field of Study, Engineering or technical degree with emphasis in mechanical and electrical systems.
Preferred: Bachelor Degree.
3-5 years previous engineering experience preferred
Medical device or pharmaceutical industry experience preferred.
Air pollution control systems installation / operation / validation experience preferred.
Ethylene Oxide sterilization installation / operation / validation experience preferred.
Minimum Knowledge, Skills, or Abilities (KSA’s):
Proficient / Working KSA
Computer skills (Microsoft Office suite, Microsoft Project, Internet, and PLC programming)
Trouble shooting skills
Mechanical and electrical systems knowledge
Project management skills
Medical device manufacturing standard knowledge
Regulatory knowledge (FDA, OSHA, EPA, DOT)
Air pollution control system
Managing change skills
Technical writing skills
Ability to work with highly regulated and complex processes
Ability to work with limited supervision
Ability to read and understand electrical and mechanical schematics and P&ID drawings.
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 LocationUSA NE - Columbus (East)
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