Sterilization Process Engineer I

Title: Sterilization Process Engineer I

Pay Rate: $25-26/hour

Employment Type: Contract

Estimated End Date: February 2026

Schedule: Full-Time, Monday Friday, Standard Business Hours (9/80 schedule; occasional off-hours support as needed)

Location: Durham, NC, 27712

Job Code: CRNGJP00028517

Tekberry is seeking a highly skilled Process Engineer I to join our client, a leading global manufacturing company. In this role, you will support sterilization technology and terminal sterilization processes across the division, collaborating with cross-functional teams to ensure operational excellence, compliance, and continuous improvement. As a W2 employee, you will have access to health benefits.

Responsibilities:

• Collaborate with site engineers, operations, and suppliers to maintain and improve sterilization processes.
• Respond quickly to production/process upsets; troubleshoot issues, diagnose problems, and implement corrective actions to reestablish operations.
• Develop and maintain SPC/SQC systems to improve process discipline and control.
• Provide technical leadership in assigned processes, escalating issues when necessary.
• Support development, validation, routine sterilization, and requalification activities.
• Review and analyze process data to identify trends and improvement opportunities.
• Monitor internal asset performance, targeting 98% uptime.
• Document changes via the change control process.
• Train maintenance and operations personnel on sterilization processes, ensuring operational efficiency and product quality.
• Provide indirect leadership to technical and hourly associates to achieve departmental quality, quantity, service, cost, and safety goals.
• Must occasionally flex working hours and respond to off-hours calls to resolve process or system downtime events.

. Must-Have Qualifications:

• 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 experimental design skills.
• Effective collaborator across organizational boundaries with ability to integrate solutions.
• Proficient in Microsoft Word, Excel, and PowerPoint.

Preferred Skills:

• Knowledge of sterilization techniques and fundamentals.
• Experience within life sciences or medical device industries.
• Familiarity with medical device quality systems and sterility assurance requirements.
• Experience with DMAIC, Lean manufacturing, and validation activities.
• Understanding of radiation, heat, filtration, and chemical sterilization methods (ISO 11135, ISO 14937, ISO 11137, ISO 13408).
• Exposure to microbiological testing and biocompatibility standards (ISO 11737, ISO 11138, ISO 14161, ISO 10993).
• Proficiency with data analysis tools such as JMP or Minitab.

We need hard-working, reliable employees. Tekberry offers a $100 payment for referrals!

Tekberry Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected categories under all applicable laws.

Tekberry, Inc is a Certified Minority Business Enterprise (MBE) and Certified Disadvantaged Business Enterprise (DBE).

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