Job Title: Senior Computerized System Validation (CSV) Consultant Location: Canada (Hybrid),Toronto Experience: 6–10 Years Domain: Life Sciences / Pharma / Biotech Please share me the resume at pranay@burgeonits.com Job Description We are looking for a Senior Computerized System Validation (CSV) Consultant with 6–10 years of experience in the Life Sciences, Pharma, or Biotech industry. The ideal candidate should have hands-on experience in the complete CSV lifecycle, validation documentation, testing, regulatory compliance, and supporting system implementations and upgrades in GxP-regulated environments. Required Skills 6–10 years of Computerized System Validation (CSV) experience Computer Software Assurance (CSA) SDLC & Validation Lifecycle Validation documentation: URS, FRS, DS, IQ, OQ, PQ, RTM, Validation Plans, Validation Summary Reports Risk Assessments & Risk-Based Validation GxP Compliance GAMP 5 FDA 21 CFR Part 11 EU Annex 11 ALCOA+ Data Integrity UAT, Functional & Regression Testing Defect, Deviation & CAPA Management Change Control HP ALM JIRA Veeva Vault ServiceNow Audit & Inspection Readiness Strong documentation, analytical, and communication skills Experience working with cross-functional global teams Experience supporting US & European clients