FDA Validation Engineer

Description JR Automation, a Hitachi Group Company, is driven to deliver customer success worldwide. We provide intelligent automated manufacturing and distribution technology solutions that transform how the world's leading manufacturers make and distribute products. Our strength is our people and we’re always looking to strengthen our team across the globe. Join us as an FDA Validation Engineer . Location type: This is an onsite position based in Nashville, TN. What You’ll Do Provide validation experience and guidance during equipment design, software design, build, debug, qualification and improvement phases of a project. Develop pertinent document templates tailored to customer SOP’s. Write overall project quality (validation scope) plans and validation summary reports. Organize, guide, and write requirement specifications. Oversee, execute and review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies. Note: This list of responsibilities is not inclusive; however, it is intended to be a guideline for activities. What You’ll Bring Bachelor’s degree in Electrical Engineering or equivalent experience, calculated as two (2) years of relevant work experience for each year of academic study. 3+ years performing validation activities in a Medical Device or Life Science environment preferred. Experience working in a GAMP 5 based validation model. Current or prior JR Automation experience, or experience in the automation industry is strongly preferred. Skills You’ll Have Ability to understand electrical/pneumatic schematic drawings. Experience with PLC Control Systems preferred. Debugging skills preferred. Other Details Travel up to 25% to customer sites & other JR locations. Train and mentor 1-2 team members as directed. Company Overview At JR Automation, A Hitachi Group Company, we discover potential, reimagine limits, and advance industry. When faced with a problem, we find a solution. Together, we push what’s possible to automate for tomorrow. Join our team of 2,000+ at one of our 20+ facilities around the world and be a part of the most experienced team of advanced automation integrators. Fueled by Possible. Equal Opportunity Employer (EOE)-Females/Minorities/Protected Veterans/Individuals with Disabilities If you need a reasonable accommodation to apply for a job at JR Automation, please send the nature of request and contact information to View email address on click.appcast.io. Queries other than accommodation requests will not be responded to. #J-18808-Ljbffr Hitachi Vantara Corporation