Validation Specialist

6 days ago


Indianapolis, Indiana, United States Kimball Electronics Full time
Job Title: Validation Engineer

We are seeking a highly skilled Validation Engineer to join our team at Kimball Electronics. As a Validation Engineer, you will be responsible for developing and executing validation plans, protocols, and reports for medical device manufacturing processes.

Key Responsibilities:
  • Develop and execute validation plans, protocols, and reports for medical device manufacturing processes
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
  • Analyze data using statistical techniques and software to ensure process validation
  • Train and mentor other engineers on validation practices and techniques
  • Lead validation review meetings and ensure documentation is up-to-date
Requirements:
  • 3-5 years of experience in medical device manufacturing
  • Bachelor's degree in Engineering or Engineering Technology
  • Knowledge of ISO13485, regulatory requirements, and FDA 21 CFR 820/GMP Medical Device Regulations
  • Experience with manufacturing processes, such as automated assembly lines, manual assembly processes, molding processes, and packaging processes
  • Validation experience, process and equipment qualification (IQ, OQ, PQ), test methods, and GR&Rs
What We Offer:
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment
  • Recognition and rewards for outstanding performance

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for validation and compliance, we encourage you to apply.


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