FDA Validation Engineer

Hitachi • Liberty, SC

1d • Onsite

About The Position

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 out of Liberty/Greenville, SC.

Requirements

• 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.
• Ability to understand electrical/pneumatic schematic drawings.

Nice To Haves

• Current or prior JR Automation experience, or experience in the automation industry is strongly preferred.
• Experience with PLC Control Systems preferred
• Debugging skills preferred

Responsibilities

• 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.
• Train and mentor 1-2 team members as directed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level