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CSV Quality Support Lead

CSI Companies is seeking a CSV Quality Support Lead to lead and execute Computer System Validation (CSV) activities across the system lifecycle. This role requires expertise in risk-based validation methodologies, validation documentation, testing, compliance, and regulatory requirements within a regulated environment.

Hours/Location/Pay/Position Type

• Location: Raritan, NJ
• Schedule: Hybrid – onsite 3 days per week in Raritan, NJ
• Hours: Monday – Friday, standard business hours
• Position Type: Contract
• Pay: $43-$55/hour

Work Authorization

• Must be authorized to work in the United States without current or future sponsorship.

What You'll Do

• Lead and execute validation deliverables across the system lifecycle, including risk assessments, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release activities.
• Apply a risk-based approach to determine validation scope, testing depth, and compliance requirements.
• Develop, review, and maintain validation documentation, including Compliance Plans, Test Protocols, Risk Assessments, Requirements Traceability Matrices (RTMs), Test Scripts, Test Summary Reports, and Compliance Reports.
• Ensure validation activities align with regulatory requirements, quality standards, and data integrity principles.
• Coordinate testing activities, document test results, and manage validation deviations through resolution.
• Partner with Quality, IT, and business stakeholders to support validated system implementations and enhancements.
• Review requirements and ensure complete traceability between requirements, testing, and final validation deliverables.
• Prepare final validation reports and support release readiness activities.
• Drive consistency and quality across validation processes and documentation.

What We're Looking For

• Advanced experience in Computer System Validation (CSV).
• Strong understanding of risk-based validation methodologies and computerized system compliance requirements.
• Experience performing risk assessments and determining validation scope based on system impact and risk.
• Experience authoring and reviewing validation documentation, including RTMs, protocols, test scripts, summary reports, and compliance reports.
• Hands-on experience with test execution, deviation management, and validation reporting.
• Knowledge of GxP principles, data integrity requirements, and regulated environments.
• Strong communication, organizational, and stakeholder management skills.
• Ability to lead multiple validation activities and collaborate across cross-functional teams.

Nice to Have

• Experience supporting audits, inspections, or compliance reviews.
• Familiarity with enterprise systems, quality systems, laboratory systems, or manufacturing systems.
• Experience leading CSV initiatives within complex regulated environments.

Who Should Apply?

This opportunity is ideal for experienced CSV professionals who enjoy leading validation efforts, driving compliance initiatives, and ensuring systems meet quality and regulatory requirements throughout the validation lifecycle.

About Us

CSI Companies is a nationally recognized workforce solutions and staffing firm specializing in healthcare, technology, finance, accounting, and professional services. Founded in 1994, CSI Companies provides comprehensive staffing and recruiting solutions to organizations nationwide. We are committed to connecting top talent with exceptional opportunities while delivering outstanding service to our clients and consultants.

Benefits Offered

• Weekly pay
• Medical, dental, and vision insurance
• Voluntary life and disability coverage
• 401(k) participation eligibility
• Paid training opportunities