Computer Systems Validation Analyst II Job at Iovance Biotherapeutics, Remote

  • Iovance Biotherapeutics
  • Remote

Job Description

Iovance Biotherapeutics seeks a Computer Systems Validation Analyst II to support the full lifecycle of computer system validation activities. The role involves creating regulatory documentation, executing validation projects, and ensuring compliance with FDA and EU requirements for laboratory, manufacturing, and enterprise systems.

Responsibilities

  • Execute Computer Systems Validation lifecycle activities and generate associated documentation
  • Develop CSV plans, risk assessments, user requirements, functional specifications, and testing protocols
  • Manage validation projects for laboratory, manufacturing, and multi-site enterprise applications
  • Implement change controls and conduct periodic system and data integrity reviews
  • Provide regular project status updates and coordinate with internal stakeholders

Requirements

  • Bachelor's degree in Information Technology, Life Science, or related technical discipline
  • 5+ years of computer systems validation or related industry experience
  • Expertise with 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles
  • Proficiency with Agile, Waterfall, and hybrid software development lifecycle models
  • Strong project management and cross-functional collaboration skills
  • Experience creating CSV documentation including protocols, specifications, and traceability matrices

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