Validation Engineer

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

The Opportunity

At STERIS, we're dedicated to creating a healthier and safer world by providing innovative healthcare and life science solutions globally. We're currently seeking a talented Validation Engineer to join our team. If you're passionate about validation, enjoy travel, and want to be a subject matter expert, this role might be perfect for you! As a Validation Engineer at STERIS, you'll play a crucial role in ensuring the reliability and compliance of our products in cGMP-regulated markets. You'll author and execute validation protocols for STERIS equipment while also providing consultative support and training to our Service Representatives and Customers. Your expertise will contribute to the development and delivery of validation-related services across pharmaceutical, biotechnology, medical device, and laboratory research sectors. If you're ready to contribute to our mission and thrive in a dynamic environment, we'd love to hear from you!

What You Will Do

• Develop, author, and execute Validation/Qualification protocols (including Cycle Development, IQOQ, and PQ) for STERIS Life Science (LS) equipment, adhering to STERIS Service and Customer requirements.

• Identify and resolve non-conformities during protocol execution, analyze results, and create final summary reports using Good Documentation Practices (GDP).

• Collaborate with Customers to define Scope of Work for formal PQ quotes and protocols based on Customer-defined load configurations.

• Create validation project schedules and support other project deliverables to meet deadlines and maintain department standards.

• Work with Specialty Services Engineering to establish validation standards, procedures, guidelines, and best practices for Life Science equipment.

• Stay informed about regulatory and industry standards for validating LS equipment.

• Train Field Service Engineers on executing standard PQ protocols and oversee their work.

Education Degree

Bachelor's Degree in Mechanical Engineering or Engineering General

What You Need To Be Successful

Education and Experience:

• Bachelor's Degree in Mechanical Engineering or Engineering General.

• Minimum one (1) to five (5) years of demonstrated experience in Qualification/Validation of process equipment, including Steam Sterilizers, Pure Steam Generators, Pure Water Stills, and cGMP Washing equipment (using cGMP, ISPE, GAMP, ASTM, and ICH guidelines).

• Proficiency in electronic/electromechanical and computer-controlled equipment.

• Demonstrated cGMP (GDP) documentation skills.

• Experience with Kaye Validator for thermal mapping of chambers and heat penetration studies.

• Understanding of appropriate handling and interpretation techniques for Biological Indicators.

Skills Required:

• Proactive self-starter with a commitment to delivering high-quality results and ensuring a positive Customer experience.

• Willingness to travel up to 50%(valid driver's license and passport required). Travel may include overnight stays and infrequently, a weekend.

• Close and easy access to a major airport is preferred.

• Ability to work under pressure and excellent oral and written communication skills.

• Strong organizational, analytical, and problem-solving abilities.

• Effective prioritization and project management skills.

• Background in generating, interpreting, and compiling raw measurement data into validated PQ records and final reports.

• Solid understanding of pharmaceutical CGMPs, FDA regulations, and other relevant requirements.

• Proficiency in Microsoft Office.

• Must have valid driver license and ability to obtain a passport.

• Travel expectation: 10% of the time globally - 40% of the time in the North USA.

What STERIS Offers:

The opportunity to join a company that will invest in you for the long-term. STERIS couldn't be where it is today without our incredible people. That's why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.

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Pay range for this opportunity is $67,750.00 - $94,762.50.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location's HR Office during normal business hours.

Req ID: 44223

Job Category: Engineering

Mentor, OH, US, 44060

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