- 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.
- Minimum two-year degree required. Bachelor's degree in Systems Engineering, Life Sciences, Electrical/Controls Engineering, or Quality Assurance or related field preferred.
- Minimum of one year performing validation activities (three or more years' experience preferred).
- Experience in custom engineered solutions, Medical Devices, or Life Sciences is preferred.
- Experience working in a GAMP 5 based validation model.
- Ability to understand electrical/pneumatic schematic drawings.
- Experience with PLC Control Systems preferred
- Debugging skills preferred
- Travel up to 25% to customer sites & other JR locations
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FDA Validation Engineer - Nashville, United States - Hitachi Energy Ltd.
Description
Location:
Nashville, Tennessee, United States of America
Job ID:
R0039203
Date Posted:
Company Name:
WRIGHT INDUSTRIES, LLC
Profession (Job Category):
Engineering & Science
Job Schedule:
Full time
Remote:
No
Job Description:
As an FDA Validation Engineer, you will work with some of the most talented engineers in the automation industry. This role will enable you to partner with our internal and customer teams on FDA equipment. The innovative solutions we work on offer diverse experiences that will strengthen your skills and challenge your abilities.
What You'll Do:
Note:
This list of responsibilities is not inclusive; however, it is intended to be a guideline for activities.
What You'll Bring:
Skills You'll Have:
Other Details:
At JR Automation, A Hitachi Group Company, our talented teams leverage the latest technologies, innovative thinking, and decades of experience to provide our global customers with world-class automation equipment.
Our people are the heart of our operations, and we believe unique skills and capabilities enable us to grow, collaborate and evolve.
Join our team of 2,200+ at one of the 27 facilities around the globe. We offer competitive pay, great benefits, apprenticeship programs, tuition reimbursement and training opportunities to develop your skills.Come Think. Solve. Create. With Us
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.
