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Validation Engineer

San Diego, CA

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RemX Specialty Staffing is seeking candidates for a contract position as a Validation Engineer for a medical device manufacturer client in San Diego.

Job Requirements

  • BS degree or equivalent in engineering or related field.
  • 3+ years of relevant industry experience.
  • Exposure to validation of in-vitro diagnostic device and medical device manufacturing
  • processes. 
  • Knowledge of analytical and physical test methods and their respective validations. 
  • Comprehensive knowledge of validation documentation. 
  • Knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO and CMDR. 

What you will be doing:

  • Provide technical expertise and guidance for the preparation and execution of validation protocols and reports. 
  • Review and troubleshoot anomalies, deviations, etc. 
  • Resolves and consults on applicable validation compliance and manufacturing process issues. 
  • Mentor and leads projects. 
  • Provide technical reviews of protocols. 
  • Contribute at the validation project team level for validation activities. 
  • Assist in developing and providing technical training. 
  • May provide guidance to less senior staff. 
  • May work with hazardous materials. 
  • Carries out duties in compliance with established business policies. 
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies. 
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. 
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