CSV Engineer

Role - CSV Engineer Location - Raritan, NJ(Hybrid) Job Details: • 5-10 years' experience in Computer System Validation of GxP systems • Must have experience in Agile methodology and handled multiple releases in parallel • Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation • 5+ years of experience in validating SAP application implementation, test script review, test execution review, test defect management. • Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA • Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC • Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams • Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report • Must be familiar with procedures, work instructions, forms and templates • Solid understanding of SDLC, Jira, QTest, automated test tools, code repository like bitbucket and change control/ management systems like ServiceNow

Created: 2026-03-10