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Validation Analysts

  • Full Time, onsite
  • Epis Data Inc
  • Hybrid2-3 Days in a Week, United States of America
Salary undisclosed

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Role: Validation Analysts
Location: Middleton, WI - Hybrid
Duration: Long term
Experience: 4 Years

REQUIREMENTS:

  • Bachelor's degree
  • 2+ years relevant GMP validation experience in the Pharma industry
  • MUST HAVE exposure/1 year experience working with "insert software" (software that pertains to PACKAGING and LABELING)
  • Experience validating software for laboratory equipment (Ex. Empower, Chromeleon, SDS (Sequence Detection Software, 32 Karat)
  • Responsible to initiate and complete performance qualification validation
  • Facilitate and validate the implementation of software systems and/or laboratory instrumentation upgrades
  • Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC)
  • Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced
  • Ability to attain, maintain, and apply a working knowledge of Google Cloud Platforms, applicable SOPs/WPDs, and process maps
  • Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans. Ability to assess the cause of test failures.
  • Excellent Interpersonal and Communication skills
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