Sterilization Engineer

Stefanini Group; Town of Texas, Round Lake (WI, IL); Hybrid; USD 60,000 - 90,000; Full time

Job summary

An innovative company is seeking a Sterilization Engineer to enhance product development and ensure sterility assurance. This role involves applying technical knowledge to various projects, understanding sterilization modalities, and executing validation protocols. Join a global leader in IT and consulting services, where your contributions will directly impact product quality and compliance with GxP regulations. If you are passionate about engineering and eager to make a difference in a collaborative environment, this opportunity is perfect for you.

Qualifications

• 3-5 years of experience in engineering with a focus on sterilization.
• Ability to write and review validation documents.

Responsibilities

• Contribute to the design and enhancement of products under supervision.
• Support product development and change controls related to sterility assurance.

Skills

Sterilization methods

Microbiological validation methods

Technical data evaluation

Validation and qualification documentation

Education

B.S. in Engineering

Job description

Stefanini is seeking a Sterilization Engineer in Round Lake, IL (Hybrid work).

For quick application, please contact Tuhin Podder via call or email.

Work Hours: Monday to Friday (40 hours)

Work Location: Round Lake, IL

Shift: 1st Shift (7:00 AM - 5:00 PM)

Responsibilities:

• Contribute to the design, development, or enhancement of new products and processes under supervisor guidance or sterility assurance focal point.
• Apply technical knowledge to various projects within sterility assurance with minimal assistance.
• Understand sterilization modalities and related disciplines.
• Use engineering tools to solve straightforward problems.
• Perform standard engineering tasks and provide technical recommendations for routine projects.
• Execute routine assignments independently within deadlines.
• Understand GxP regulations and guidance.
• Support product development and change controls related to sterility assurance.
• Write, execute, and review validation and qualification protocols and reports.
• Evaluate technical data and test results.
• Apply engineering principles to small projects.

Must Have:

• B.S. in Engineering with 3-5 years of related experience.
• Basic understanding of sterilization methods (Moist Heat, Aseptic, Irradiation).
• Knowledge of microbiological validation methods (sterility, bioburden, endotoxin).
• Ability to write and review validation and qualification documents.
• Skill in evaluating technical data and test results.

Nice to Have:

• Understanding of aseptic techniques (RAII).
• Ability to conduct experiments with minimal assistance.
• Knowledge of GxP regulations.

Salary ranges may vary based on experience and market conditions. Some positions may include bonuses or incentives.

Stefanini values top talent and transparent hiring processes, including phone discussions about the role, interviews, and offers.

About Stefanini Group

Global provider of IT, consulting, and staffing services to Fortune 1000 companies, with a presence across the Americas, Europe, Africa, and Asia. Recognized as a CMM Level 5 company.