Validation Engineer

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!

Note: Remote role with ~40% travel to customer sites (some international); local candidates near Cleveland/Mentor, OH preferred.

• 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.

Required:

• Bachelor's Degree in Mechanical Engineering, Bio Medical, Bio engineering, Chemical or Engineering General is required.
• 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 or equivalent for thermal mapping of chambers and heat penetration studies.
• Understanding of appropriate handling and interpretation techniques for Biological Indicators.
• Proactive self-starter with a commitment to delivering high-quality results and ensuring a positive Customer experience.
• Willingness to travel up to 50%
• 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.