Hitachi

FDA Validation Engineer

Hitachi  •  United States (Onsite)  •  3 months ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description

Location:

Nashville, Tennessee, United States of America

Job ID:

R0116645

Date Posted:

2026-02-17

Company Name:

WRIGHT INDUSTRIES, LLC

Profession (Job Category):

Engineering & Science

Job Schedule:

Full time

Remote:

No

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 anFDA 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.



AtJR 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 jrcareers@jrautomation.com. Queries other than accommodation requests will not be responded to.

Hitachi

About Hitachi

Since its founding in 1910, Hitachi has responded to the expectations of society and its customers through technology and innovation. Our mission is to “Contribute to society through the development of superior, original technology and products.” Over the past 100+ years this commitment has led us to work towards creating a more sustainable society through our “Social Innovation Business”. We work to apply our expertise in information technology (IT), operational technology (OT), and a wide variety of products to advance social infrastructure systems and improve quality of life across the world.

Hitachi’s Social Innovation Business is centered around 5 growth sectors: Mobility, Smart Life, Industry, Energy, and IT. Globally, we have nearly 300,000 employees who are working to improve people’s quality of life and our customers’ social, environmental, and economic values to create a sustainable future. The challenges we face as a society are unprecedented, but so are the opportunities. Together, let’s start powering good.

Industry
IT & Software
Company Size
10,000+ employees
Headquarters
Tokyo, JP
Year Founded
Unknown
Social Media