Job Description


Job Description:
Job Summary:
  • CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches.
  • The role involves working within the System Development Lifecycle (SDLC) and contributing to validation documentation and testing processes.
  • Strong verbal and written communication skills
    • Experience:
  • Experience in the pharmaceutical, biotechnology, or medical device industry
  • + years of experience with System Development Lifecycle (SDLC)
  • + years of experience in Computer System Validation (CSV)
  • Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation
  • Knowledge of FDA guidance and industry standards (, GAMP)
  • Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability t...

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