FDA Validation Engineer

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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 We Offer:

• Competitive wages, medical benefits starting your first day, and paid parental leave
• Opportunity to work on unique, custom automation projects
• A collaborative, engineering-driven environment
• Career growth and skill development opportunities
• A role where craftsmanship and quality truly matter

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.
• Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance 
  with validation policies.
• Interface with internal and client validation and engineering teams to secure document approvals. 
• Oversee and execute validation qualifications at our facility and at the customer’s site. 
• Create validation summary reports. 
• Provide input to address validation deviations and/or change requests and identify qualification 
  requirements to ensure compliance to system’s current validated state and all cGxP's. 
• Drive a quality approach into the organization, change control, and documentation for the equipment 
  design, software, and documentation. 
• Support all aspects of the Validation life cycle, from design through operation and improvement. 
• Travel up to 25% to customer sites & other JR locations

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
• Ability to understand electrical/pneumatic schematic drawings.
• Experience with PLC Control Systems preferred
• Debugging skills preferred

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 [email protected]. Queries other than accommodation requests will not be responded to.