Validation Engineer

STERIS CORPORATION • Cleveland, OH • 6h ago

Validation Engineer
Req ID:
51616
Job Category:
Engineering
Location:
Cleveland, OH, US, 44114
Workplace Type:
Hybrid
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.
Position Summary
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.
What You'll Do As A Validation Engineer
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.
The Experience, Skills, and Abilities Needed
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.
Pay range for

Similar Jobs

Staff Engineer - Road - Cleveland, OH

American Structurepoint, Inc. • Cleveland, OH • 1h ago

IT & Engineering

Staff Engineer - Road - Cleveland, OH Job Locations US-OH-Cleveland Job ID 2025-2713 Category/Group Campus Employment Type Regular Full-Time Overview Join American Structurepoint and become part of a team that goes the e...

1h ago

Go to Apply

Bridge Engineers (all levels - EI/EIT, PE, Sr-level/PM)

CTL Engineering, Inc. • Cleveland, OH • 1h ago

IT & Engineering

CTL Engineering is hiring Structural | Bridge Engineers (all levels - EI/EIT, PE, Sr-level/PM)! We are hiring for all career levels at our Brunswick office (south Cleveland): New grad/entry level Mid-career Senior-level/...

1h ago

Go to Apply

Technical Specialist, On-site Support

Lincoln Electric • Cleveland, OH • 1h ago

IT & Engineering

Lincoln Electric is the world leader in the engineering, design, and manufacturing of advanced arc welding solutions, automated joining, assembly and cutting systems, plasma and oxy-fuel cutting equipment, and has a lead...

1h ago

Go to Apply

Channel Solutions Engineer, Technical Alliances

Keyfactor, Inc. • Independence, OH • 1h ago

IT & Engineering

About Keyfactor Our mission is to build a connected society, rooted in trust, with identity-first security for every machine and human. Keyfactor helps organizations move fast to establish digital trust at scale - and th...

1h ago

Go to Apply

Senior Business Intelligence Analyst

GLOBAL PAYMENT HOLDING COMPANY • Lakewood, OH • 2h ago

IT & Engineering

Every day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services. Our worldwide team helps over 3...

2h ago

Go to Apply

Manufacturing Engineering, Other

Rotek Incorporated • Aurora, OH • 5h ago

IT & Engineering

Company As one of the world's leading manufacturers of slewing bearings, thyssenkrupp rothe erde leads the way. We develop solutions for the most diverse applications which all have something in common: They transcend th...

5h ago

Go to Apply

Field Engineer

Keller Foundations, LLC • Cleveland, OH • 6h ago

IT & Engineering

Company Logo Overview Keller is the world leader in geotechnical construction and deep foundations. With a North American presence of over 100 years, we operate as the market leader with over 50 offices throughout the US...

6h ago

Go to Apply

Process Engineer

Tremco Incorporated • Cleveland, OH • 6h ago

IT & Engineering

Tremco Construction Products Group brings together Tremco CPG Inc.'s Commercial Sealants & Waterproofing and Roofing & Building Maintenance divisions; Tremco Barrier Solutions Inc.; Dryvit, Nudura and Willseal br...

6h ago

Go to Apply

Automation Technician- 3rd Shift

Rockwell Automation, Inc. • Twinsburg, OH • 6h ago

IT & Engineering

Twinsburg, Ohio, United States Rockwell Automation is a global technology leader focused on helping the world's manufacturers be more productive, sustainable, and agile. With more than 28,000 employees who make the world...

6h ago

Go to Apply

Senior Project Fuel Facility Engineer

C&S Engineers, Inc. • Cleveland, OH • 6h ago

IT & Engineering

At C&S Companies, we believe work environment, culture, and the opportunity to learn, and grow are key elements when considering a new job. We are just the right size to provide the resources and support you need wit...

6h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.