Sterilization Process Engineer
- Durham, NC
- Permanent
- Full-time
- Actively collaborate with other site engineers, operations personnel, and suppliers to maintain and improve operations
- Work with operations to gather support needed, information, and provide updates on process status
- Quickly respond to production and process upsets, troubleshoot production issues, diagnose problems, and implement corrective action (machine fix, process change, etc.) to reestablish operations
- Work with operations to further develop SPC/SQC for process discipline and control (PD/PC)
- Provides technical leadership in assigned processes and escalate issues appropriately
- Act to continuously improve and expand the core process capabilities
- Use of engineering first principles like MEE to drive mechanistic understanding and root cause identifications
- Responsible for providing technical expertise and strategic direction for sterilization
- Supporting and executing activities related to development, validation, routine sterilization and requalification activities
- Lead and work collaboratively across project teams as assigned, which may include commercial product support, continuous improvement activities, innovation projects, or other activities related to sterilization
- Reviewing and analyzing process data for trends and improvement areas
- Monitor internal asset performance with focus to 98% uptime
- Documents changes via the change control process
- Train maintenance and operations personnel on processes and machinery to transfer operations knowledge and ensure operational efficiency and product quality
- Provide indirect leadership to assigned technical and hourly associates to achieve departmental quality, quantity, service, cost, and safety goals
- Minimum Bachelor’s degree in engineering, material science, physics, physical science or other related science degree program
- 0-3 years experience in engineering or manufacturing environments
- Creative/innovative problem solving
- Able to collaborate across organizational boundaries and integrate solutions
- Strong experimental practices and engineering problem solving; can understand fundamentals and recognize deviations and implement routine solutions
- Proficient in the use of software programs such as MS Word, Excel, PowerPoint
- Broad knowledge of sterilization techniques and fundamentals
- Become a subject matter expert in sterilization technology
- Experience with radiation technology, electron beam (e-beam) nuclear applications, physics, gamma irradiation or technology transferable to product sterilization via radiation technologies
- Experience within the Life Sciences or medical device industries
- Medical device quality systems and sterility assurance requirements
- DMAIC and/or lean manufacturing principles
- Equipment and product design and validation experience
- Familiarity with radiation, heat, filtration, and chemical sterilization methods and associated international standards (ISO 11135, ISO 14937, ISO 11137, ISO 13408)
- Working knowledge of microbiological testing, biocompatibility and associated international standards (ISO 11737, ISO 11138, ISO 14161, ISO 10993) required to support sterilization process validation
- Experience working with data analysis software (JMP, Minitab, etc..)
- Excellent growth and advancement opportunities