Location:Liberty, South Carolina, United StatesJob ID: R0081207Date Posted:2025-03-05Company Name:J.R. AUTOMATION TECHNOLOGIES, LLCProfession (Job Category):Engineering &amp; ScienceJob Schedule: Full timeRemote:NoJob Description:As a 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:  <ul><li>Provide validation experience and guidance during equipment design, software design, build, debug, qualification and improvement phases of a project.  </li><li>Develop pertinent document templates tailored to customer SOP’s.  </li><li>Write overall project quality (validation scope) plans and validation summary reports.  </li><li>Organize, guide, and write requirement specifications. </li><li>Oversee, execute and review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies. </li></ul>Note: This list of responsibilities is not inclusive; however, it is intended to be a guideline for activities.  What You’ll Bring: <ul><li>Bachelor's degree in Electrical Engineering or related field. </li><li>3+ years performing validation activities in a Medical Device or Life Science environment preferred. </li><li>Experience working in a GAMP 5 based validation model.   </li></ul>Skills You’ll Have:  <ul><li>Ability to understand electrical/pneumatic schematic drawings. </li><li>Experience with PLC Control Systems preferred </li><li>Debugging skills preferred </li></ul>Other Details:  <ul><li>Travel up to 25% to customer sites &amp; other JR locations </li><li>Train and mentor 1-2 team members as directed. </li></ul>Company Overview 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.  We transform processes &amp; optimize operations with the solutions we design, build, program &amp; 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.   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.      Fueled by PossibleEqual 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 jrcareers@jrautomation.com. Queries other than accommodation requests will not be responded to.

Hitachi Energy is a global technology leader that is advancing a sustainable energy future for all. We serve customers in the utility, industry and infrastructure sectors with innovative solutions and services across the value chain. Together with customers and partners, we pioneer technologies and enable the digital transformation required to accelerate the energy transition towards a carbon-neutral future. We are advancing the world&rsquo;s energy system to become more sustainable, flexible and secure whilst balancing social, environmental and economic value. Hitachi Energy has a proven track record and unparalleled installed base in more than 140 countries.

FDA Validation Engineer

Location:Liberty, South Carolina, United StatesJob ID: R0081207Date Posted:2025-03-05Company Name:J.R. AUTOMATION TECHNOLOGIES, LLCProfession (Job Category):Engineering &amp; ScienceJob Schedule:&nbsp;Full timeRemote:NoJob Description:As a FDA Validation Engineer, you will work with some of the most talented engineers in the automation industry.&nbsp; This role will enable you to partner with our internal and customer teams on FDA equipment.&nbsp; The innovative solutions we work on offer diverse experiences that will strengthen your skills and challenge your abilities.&nbsp;What You’ll Do:&nbsp;&nbsp;<ul><li>Provide validation experience and guidance during equipment design, software design, build, debug, qualification and improvement phases of a project.&nbsp;&nbsp;</li><li>Develop pertinent document templates tailored to customer SOP’s.&nbsp;&nbsp;</li><li>Write overall project quality (validation scope) plans and validation summary reports.&nbsp;&nbsp;</li><li>Organize, guide, and write requirement specifications.&nbsp;</li><li>Oversee, execute and review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies.&nbsp;</li></ul>Note: This list of responsibilities is not inclusive; however, it is intended to be a guideline for activities.&nbsp;&nbsp;What You’ll Bring:&nbsp;<ul><li>Bachelor's degree in Electrical Engineering or related field.&nbsp;</li><li>3+ years performing validation activities in a Medical Device or Life Science environment preferred.&nbsp;</li><li>Experience working in a GAMP 5 based validation model.&nbsp; &nbsp;</li></ul>Skills You’ll Have:&nbsp;&nbsp;<ul><li>Ability to understand electrical/pneumatic schematic drawings.&nbsp;</li><li>Experience with PLC Control Systems preferred&nbsp;</li><li>Debugging skills preferred&nbsp;</li></ul>Other Details:&nbsp;&nbsp;<ul><li>Travel up to 25% to customer sites &amp; other JR locations&nbsp;</li><li>Train and mentor 1-2 team members as directed.&nbsp;</li></ul>Company Overview&nbsp;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.&nbsp;&nbsp;We transform processes &amp; optimize operations with the&nbsp;solutions we design, build,&nbsp;program &amp; deploy&nbsp;for&nbsp;nearly every industry.&nbsp;&nbsp;Our people are the heart of our operations, and we believe unique skills and capabilities enable us to grow, collaborate and evolve.&nbsp;&nbsp;&nbsp;Join our team of 2,200+ at one of the 27 facilities around the globe.&nbsp;&nbsp;We offer competitive&nbsp;pay,&nbsp;great benefits, apprenticeship programs, tuition reimbursement and training opportunities to develop your skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Fueled by PossibleEqual 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 jrcareers@jrautomation.com. Queries other than accommodation requests will not be responded to.

FDA Validation Engineer

About the Job

About the Company

HITACHI ENERGY

Similar Jobs

Validation Engineer

Validation Engineer

Certification Engineer

Certification Engineer

Quality Engineer

Quality Engineer

Test Engineer

Test Engineer

Electrical Compliance Test Engineer

Electrical Compliance Test Engineer

Validation Test Technician

Validation Test Technician

Test Development Engineer

Test Development Engineer

Product Safety Engineer

Product Safety Engineer

Product Safety Engineer

Product Safety Engineer

Software Development Engineer - Systems Test

Software Development Engineer - Systems Test