Computer Systems Validation Analyst II

Job Summary

Supporting all aspects of the Computer Systems Validation (CSV) Lifecycle, the full-time remote Computer Systems Validation Analyst II will create documentation, execute implementation tasks, and manage project timelines while ensuring compliance with regulatory standards such as 21 CFR Part 11 and EU Annex 11.

Key responsibilities

• Execute and document all CSV activities, including risk assessments, user requirements, and validation protocols
• Ensure project deadlines and performance standards are met while providing frequent status updates to management and clients
• Collaborate with internal teams to deliver validated computer systems and manage periodic reviews of data integrity

Required qualifications

• Degree in Information Technology, Life Science, or a related technical discipline
• 5+ years of relevant industry experience in computer systems validation
• Demonstrated project management ability with experience in Agile, Waterfall, or hybrid SDLC models
• Strong knowledge of computerized system lifecycle activities and IT controls in a regulated environment
• Detail-oriented mindset with a focus on accuracy and compliance in documentation