Computer System Validation (CSV) Engineer

Required Skills

3+ years of experience in Computer System Validation in a regulated environment
Strong knowledge of GxP, 21 CFR Part 11, data integrity
Hands‑on experience with IQ/OQ/PQ, URS, validation testing & documentation
Experience with risk‑based validation (CSA)
Strong communication & cross‑functional collaboration skills

Key Responsibilities

Lead CSV activities for regulated R&D tools (JIRA, Confluence, IBM RQM/DNG, GitHub, JFrog)
Create and maintain validation deliverables (URS, IQ/OQ/PQ, UAT, test scripts, reports)
Execute risk‑based (CSA) validation and manage change control & impact assessments
Support system lifecycle management and user access administration
Partner with Quality, IT, and Engineering teams to ensure compliance
Support internal/external audits, inspections, CAPAs, and deviations
Manage tool‑related requests via ServiceNow

Preferred

Experience with JIRA, Confluence, IBM RQM/DNG, GitHub, JFrog
Exposure to audits and regulated R&D environments
Medical device or pharmaceutical domain experience