Hitachi Energy · 22 hours ago
FDA Validation Engineer
Liberty, South Carolina, United States
Full-time
Onsite
Mid Level
3+ years expJR Automation, a Hitachi Group Company, is driven to deliver customer success worldwide by providing intelligent automated manufacturing and distribution technology solutions. They are seeking an FDA Validation Engineer to provide validation experience and guidance during various project phases, ensuring compliance with validation policies.
EnergyManufacturing
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
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
Preferred
Experience with PLC Control Systems preferred
Debugging skills preferred
Company
Hitachi Energy
Hitachi Energy is a renewable energy company that provides energy consulting services.
10001+ employees
H1B Sponsorship
Hitachi Energy 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 (71)
2024 (52)
2023 (53)
2022 (58)
Funding
Current Stage
Public CompanyTotal Funding
$300M2025-03-19Post Ipo Equity· $300M
2020-03-30IPO
Leadership Team
Ron Hunt
CFO Enterprise Software Solutions
Allie Anzelone
Site HR Business Partner
Recent News
Business Standard India
2025-05-17
Company data provided by crunchbase