CSV Engineer

Raritan, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 29-08-2025

Vacancies: 1 Vacancy

Job Summary

Roles & Responsibilities:

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 Service now 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 guidances 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.

Roles & Responsibilities: 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 ...