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FDA Validation Specialist

2 months ago

Liberty, South Carolina, United States Hitachi Full time
Job Summary

As a skilled FDA Validation Engineer, you will collaborate with our talented teams to develop innovative solutions for FDA equipment. This role offers diverse experiences that will strengthen your skills and challenge your abilities.

Key Responsibilities
  • Provide validation expertise and guidance during equipment design, software design, build, debug, qualification, and improvement phases of a project.
  • Develop relevant document templates tailored to customer SOPs.
  • 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, and compliance with validation policies.
Requirements
  • Bachelor's degree in Electrical Engineering or a related field.
  • 3+ years of experience performing validation activities in a Medical Device or Life Science environment, preferably in a GAMP 5-based validation model.
Preferred Skills
  • Ability to understand electrical/pneumatic schematic drawings.
  • Experience with PLC Control Systems.
  • Debugging skills.
Additional Details
  • Travel up to 25% to customer sites and other JR locations.
  • Train and mentor 1-2 team members as directed.
About Us

At JR Automation, A Hitachi Group Company, we leverage the latest technologies, innovative thinking, and decades of experience to provide our global customers with world-class automation equipment. We transform processes and optimize operations with the solutions we design, build, program, and deploy for nearly every industry. Our people are the heart of our operations, and we believe unique skills and capabilities enable us to grow, collaborate, and evolve.

We offer competitive pay, great benefits, apprenticeship programs, tuition reimbursement, and training opportunities to develop your skills.