Computer Systems Validation Analyst II

Role overview Support the validation lifecycle for computerized systems used in regulated environments. The analyst prepares and executes validation work, coordinates delivery across project teams, and helps maintain compliance, data integrity, and reliable system records.

Responsibilities - Prepare and maintain validation lifecycle materials, including plans, requirements, risk assessments, specifications, test records, traceability matrices, qualification protocols, and final reviews. - Execute validation activities and document results for laboratory, manufacturing, and enterprise systems. - Apply change controls and coordinate assigned actions through completion. - Conduct periodic reviews of computerized systems and assess data integrity and data quality. - Track deadlines, provide project updates, respond to stakeholder questions, and escalate issues as needed. - Work with internal teams to deliver validated systems using Agile, Waterfall, or hybrid development processes.

Requirements - Degree in information technology, life sciences, or a technical discipline. - At least five years of relevant industry experience. - Working knowledge of computer system validation, regulated IT controls, and lifecycle activities. - Experience applying 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles. - Strong project coordination, written communication, troubleshooting, and organization skills. - Able to manage multiple validation activities independently, maintain precise documentation, and meet deadlines.

Benefits and work setup - Remote or professional office environment, with standard computer equipment. The listed annual base salary range is $120,000–$135,000; individual offers depend on location, responsibilities, education, experience, and skills.