FDA Validation Specialist
2 days ago
We are seeking a highly skilled FDA Validation Engineer to join our team at JR Automation, A Hitachi Group Company. As a key member of our engineering team, you will play a critical role in ensuring the quality and compliance of our medical device equipment.
Key Responsibilities- Provide validation expertise and guidance during equipment design, software development, build, debug, qualification, and improvement phases of a project.
- Develop and maintain 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, and compliance with validation policies.
- Bachelor's degree in Electrical Engineering or a related field.
- 3+ years of experience performing validation activities in a Medical Device or Life Science environment, preferably in a GAMP 5-based validation model.
- Experience working with PLC Control Systems and debugging skills are highly desirable.
At JR Automation, we leverage the latest technologies, innovative thinking, and decades of experience to provide our global customers with world-class automation equipment. We transform processes and optimize operations with the solutions we design, build, program, and 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.
We offer competitive pay, great benefits, apprenticeship programs, tuition reimbursement, and training opportunities to develop your skills. 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.
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FDA Validation Engineer
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Liberty, South Carolina, United States Hitachi Full timeAbout the RoleWe are seeking a highly skilled FDA Validation Engineer to join our team at JR Automation, A Hitachi Group Company. As a key member of our team, you will be responsible for ensuring the quality and compliance of our medical device equipment.Key ResponsibilitiesProvide validation expertise and guidance during equipment design, software design,...
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