Role - CSV EngineerLocation - Raritan, NJ(Hybrid)Job Details:5-10 years' experience in Computer System Validation of SAP Application ImplementationMust have experience in Agile methodology and handled multiple releases in parallelExtensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation5+ 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, JIRAGuide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLCApplication 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 teamsExperience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary ReportMust be familiar with procedures, work instructions, forms and templatesSolid understanding of SDLC, Jira, QTest, automated test tools, code repository like bitbucket and change control/ management systems.
