CSV Specialist

Job Title : CSV Specialist

Location : Raritan, NJ (Hybrid)

Duration : 12+ Months Contract

Experience : 5+ years

Job Summary

We are seeking an experienced CSV Specialist to support validation and testing activities for regulated systems within clinical, supply chain, or safety domains. This role involves developing, executing, and maintaining validation documentation in compliance with FDA regulations and industry standards, while ensuring systems meet both quality and business requirements.

Key Responsibilities

Validation & Compliance

Lead and execute Computer System Validation activities to ensure systems comply with FDA, GxP, and 21 CFR Part 11 requirements.

Apply GAMP 5 and risk-based validation approaches to deliver compliant and efficient validation solutions.

Develop, review, and maintain validation documentation including Validation Plans, Test Scripts, Traceability Matrices, and Summary Reports.

Ensure all documentation meets internal quality standards and regulatory expectations.

Testing & Quality Assurance

Create detailed test plans, test cases, and test scripts to validate system functionality and performance.

Execute manual tests , identify issues or deviations, and track them to resolution.

Collaborate with development teams to troubleshoot and ensure timely defect closure.

Monitor and report on test progress, coverage, and quality metrics to stakeholders.

Project & Stakeholder Management

Work closely with cross-functional teams across IT, Quality, and Business functions to align validation activities with project timelines.

Support project management tools such as JIRA and qTest for tracking deliverables and test execution.

Communicate validation strategies, risks, and outcomes effectively to management and team members.

Continuous Improvement

Identify and implement improvements in validation processes, documentation templates, and quality practices.

Stay current with evolving regulatory expectations and validation best practices.

Required Skills & Qualifications

Minimum 5 years of hands-on experience in Computer System Validation within the pharmaceutical, biotech, or life sciences industry.

Proven experience in one or more domains : Clinical Development, Supply Chain, or Drug Safety.

Strong working knowledge of FDA regulations (21 CFR Part 11), GAMP 5, and Risk-Based Validation principles.

Proficiency with JIRA, qTest , and other project or test management tools.

Excellent analytical, problem-solving, and documentation skills.

Strong communication and collaboration abilities to work effectively with cross-functional teams.