Computer Systems Validation Analyst II

Iovance Biotherapeutics

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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Vacancy posted 2 days ago

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