FDA Validation Engineer
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Job Location:
Nashville, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Location:
Nashville Tennessee United States of AmericaJob ID:
R0116645Date Posted:
Company Name:
WRIGHT INDUSTRIES LLCProfession (Job Category):
Engineering & ScienceJob Schedule:
Full timeRemote:
NoJob Description:
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 worlds leading manufacturers make and distribute products. Our strength is our people and were 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 Youll 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 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 compliance with validation policies.
Note: This list of responsibilities is not inclusive; however it is intended to be a guideline for activities.
What Youll Bring
- Bachelors 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.
Skills Youll Have
- Ability to understand electrical/pneumatic schematic drawings.
- Experience with PLC Control Systems preferred
- Debugging skills preferred
Other Details
- Travel up to 25% to customer sites & other JR locations
- Train and mentor 1-2 team members as directed.
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 whats possible to automate for tomorrow.
Join our team of 2000 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 Queries other than accommodation requests will not be responded to.
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Discover how Hitachi Rail is connecting the future of mobility through integrated rail solutions, across rolling stock, signalling, digital technology and more.
