CSV Engineer

Role: CSV Engineer

Location: Raritan, NJ (Onsite)

Experience: 5 - 10 Years

Job Description: We are seeking an experienced CSV Engineer with a strong background in Computer System Validation for GxP-regulated environments. The ideal candidate will have hands-on expertise in validating SAP applications, tool validation, and applying FDA and industry standards to ensure compliance.

Key Responsibilities:

Perform Computer System Validation (CSV) for GxP systems following FDA guidelines, GAMP, and industry standards.

Lead and support CSV activities including auditing, documentation, and revision of validation deliverables.

Validate SAP application implementations including test script reviews, execution oversight, and defect management.

Guide project teams on applicable deliverables based on project type, category, and SDLC requirements.

Apply risk-based approaches to validation with strong knowledge of 21 CFR Part 11 compliance.

Draft, review, and approve CSV deliverables such as Compliance Analysis, Plans, Test Protocols, Test Reports, and Compliance Summaries.

Work with tools like Jira, QTest, Bitbucket, automated test tools, and change control systems (e.g., ServiceNow).

Support validation of IT tools like ServiceNow, JIRA, and automation platforms.

Ensure adherence to procedures, work instructions, forms, and templates.

Required Skills & Experience:

5–10 years of experience in Computer System Validation (CSV) of GxP systems.

Strong expertise in Agile methodology and managing multiple parallel releases.

5+ years of SAP validation experience (implementation and testing lifecycle).

Experience in tool validation (ServiceNow, automation tools, JIRA).

Deep understanding of SDLC, compliance requirements, and risk-based validation approaches.

Familiarity with FDA guidance, GAMP, and 21 CFR Part 11.

Strong communication and documentation skills.

Primary Skill: Pharma Validation & Verification – Computer System Validation (CSV).