Role - Computer System Validation 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 |