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Computer System Validation (CSV) Engineer
Computer System Validation (CSV) EngineerKatalyst Healthcares and Life Sciences • Boston, MA, United States
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Computer System Validation (CSV) Engineer

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Life Sciences • Boston, MA, United States
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Responsibilities :

  • Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc.
  • uthor and maintain validation deliverables : URS, FS, DS, IQ, OQ, PQ, and traceability matrices.
  • Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Support system implementations, upgrades, and periodic reviews.
  • Collaborate with QA, IT, and business users to drive validation strategy.
  • Participate in audits and inspections to demonstrate compliance.

Requirements :

  • Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
  • 2+ years of hands-on CSV experience in pharma, biotech, or medical device environments.
  • Strong working knowledge of GxP, FDA regulations, and SDLC methodologies.
  • Experience validating cloud-based or SaaS GxP systems is a plus.
  • Excellent documentation, communication, and collaboration skills.
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