
Sterilization Process Engineer
- Durham, NC
- Contract
- Full-time
Job Title: Sterilization Process Engineer
Location: Durham, NC
Pay Rate: Based on experience
Work Hours: M-F 8am-5pm
Education: Bachelor’s degree in engineering, material science, physics, physical science, or related disciplineDescription
The Sterilization Process Engineer will support sterilization technology and terminal sterilization processes across the division. This role will provide technical expertise in development, engineering, and manufacturing projects while collaborating with cross-functional teams including Operations, Quality, and Engineering. The engineer will be responsible for both internal sterilization equipment/process support and vendor interface activities.Requirements
- Collaborate with site engineers, operations personnel, and suppliers to maintain and improve sterilization operations
- Troubleshoot and respond to production and process upsets, implementing corrective actions
- Develop and apply SPC/SQC for process discipline and control
- Provide technical leadership and escalate issues appropriately
- Continuously improve and expand sterilization process capabilities using engineering first principles
- Support development, validation, and requalification of sterilization processes
- Lead and participate in project teams for commercial support, continuous improvement, and innovation initiatives
- Review and analyze process data to identify trends and improvement opportunities
- Monitor asset performance with a focus on maintaining 98% uptime
- Document changes using the change control process
- Train operations and maintenance teams to ensure efficiency and quality
- Respond to off-hours calls on a rotating basis to resolve process upsets or downtime events
- Bachelor’s degree in engineering, material science, physics, physical science, or related field
- 0–3 years of engineering or manufacturing experience
- Strong problem-solving and innovative thinking skills
- Ability to collaborate across teams and integrate solutions
- Solid experimental practices and problem-solving abilities
- Proficiency in MS Word, Excel, and PowerPoint
- Knowledge of sterilization techniques and fundamentals
- Experience with radiation technology, e-beam, gamma irradiation, or similar sterilization processes
- Background in Life Sciences or medical device industries
- Understanding of medical device quality systems and sterility assurance
- Familiarity with lean manufacturing or DMAIC methodologies
- Equipment and product design/validation experience
- Knowledge of sterilization standards (ISO 11135, ISO 14937, ISO 11137, ISO 13408)
- Working knowledge of microbiological testing, biocompatibility, and related standards (ISO 11737, ISO 11138, ISO 14161, ISO 10993)
- Experience with data analysis software (JMP, Minitab)
- No third party resumes will be accepted
- Drug testing and/or other employment-related inquiries may be conducted
- CTG will consider for employment qualified applicants with criminal histories in a manner consistent with all applicable local, state, and federal laws
- All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third party vendors)
- CTG is an Equal Employment Opportunity employer
- CTG is an E-Verify Company