FDA Validation Engineer

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:  

• 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. 

Note: This list of responsibilities is not inclusive; however, it is intended to be a guideline for activities.  

What You’ll Bring: 

• Bachelor's degree in Electrical Engineering or related field. 
• 3+ years performing validation activities in a Medical Device or Life Science environment preferred. 
• Experience working in a GAMP 5 based validation model.   

Skills You’ll 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, 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 & optimize operations with the solutions we design, build, program & 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.      

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 [email protected]. Queries other than accommodation requests will not be responded to.