CSV Engineer

Job Title: CSV Engineer Location: Raritan, NJ (Hybrid)

Experience: 7+ Years Contract Duration: 12+ Months

Key Responsibilities

Lead and execute Computer System Validation (CSV) activities for ServiceNow Operational Technology tools.

Apply Agile methodology while managing multiple releases in parallel.

Develop, review, and update CSV documentation , including compliance analysis, plans, protocols, reports, and summaries.

Validate SAP application implementations with focus on test script review, test execution, and defect management.

Support tool validation projects for platforms such as ServiceNow, automation tools, and JIRA .

Provide guidance to project teams on SDLC deliverables based on project type and regulatory category.

Ensure compliance with FDA guidelines , GAMP standards , and 21 CFR Part 11 using a risk-based approach.

Draft, review, and approve validation deliverables in line with company procedures, work instructions, forms, and templates.

Collaborate with teams using SDLC, Jira, QTest, automated test tools, Bitbucket , and change control systems (e.g., ServiceNow).

Conduct CSV audits and ensure compliance with internal and regulatory quality requirements.

Required Experience & Skills

7+ years in Computer System Validation (CSV) .

Hands-on experience with ServiceNow tool validation .

5+ years in SAP application validation .

Strong knowledge of Agile practices in validation projects.

Expertise in CSV auditing, documentation, and regulatory compliance .

Deep understanding of 21 CFR Part 11 , GAMP 5 , and risk-based validation approaches .

Familiarity with change management systems and automated test environments .