Engineer, Medical Device, Equipment and Method validation – Hybrid (JP15110)

3 Key ConsultingThousand Oaks, CA
$36 - $41Hybrid

About The Position

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations.

Requirements

  • Method Development and Validation
  • New equipment validation
  • IQ OQ PQ
  • Supported lifecycle documentation
  • Gauge Repeatability and Reproducibility studies
  • Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
  • No Medical Device experience

Nice To Haves

  • Previous intern experience is a plus
  • Experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics.

Responsibilities

  • Executed equipment and method validation activities, including development and execution of IQ/OQ protocols, equipment characterization studies, and performance qualification support in a regulated manufacturing environment.
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