JR Automation · 13 hours ago
FDA Validation Engineer
Liberty, SC
Full-time
Onsite
Mid Level
3+ years expJR Automation, a Hitachi Group Company, is dedicated to delivering intelligent automated manufacturing and distribution technology solutions. They are seeking an FDA Validation Engineer to provide validation experience during various project phases, develop document templates, and oversee qualification packages for compliance and accuracy.
SoftwareInternet of ThingsInformation TechnologyProduct DesignSmart Home
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
Qualification
Required
Bachelor's degree in Electrical Engineering or equivalent experience, calculated as two (2) years of relevant work experience for each year of academic study
Ability to understand electrical/pneumatic schematic drawings
Preferred
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
Experience with PLC Control Systems preferred
Debugging skills preferred
Company
JR Automation
JR Automation is a leading global integrator of custom automated systems for manufacturing and distribution environments around the world.
1001-5000 employees
H1B Sponsorship
JR Automation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (6)
2023 (1)
2022 (5)
2021 (13)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
unknown2019-04-24Acquired
Leadership Team
David DeGraaf
Chief Executive Officer
Joe Shelata
Chief Financial Officer
Recent News
Company data provided by crunchbase