CSV Quality Support Lead

CSI Companies is seeking an experienced CSV Quality Support Lead to support Computer System Validation activities within a regulated environment. This role focuses on leading validation efforts across the system lifecycle while ensuring compliance with regulatory requirements, quality standards, and risk based validation methodologies.

This opportunity is ideal for a validation professional who has strong Computer System Validation experience and enjoys leading validation work streams, managing compliance documentation, and partnering with quality, business, and technical teams to support successful system implementations.

You will work closely with project teams, quality organizations, and business stakeholders to ensure validated systems are compliant, well documented, and audit ready.

Hours: Standard business hours

Pay: Competitive rate based on experience, education, and credentials

Position Type: Consultant

• Candidates must be authorized to work in the United States and eligible for W2 employment. No sponsorship and no corp to corp arrangements are available.

• Lead and execute Computer System Validation deliverables throughout the system lifecycle
• Develop validation strategies utilizing risk based methodologies
• Conduct system impact assessments and functional risk assessments
• Define validation scope and testing approaches based on GxP impact, patient risk, product risk, and data integrity considerations
• Author and review validation documentation and compliance deliverables
• Develop and maintain requirements traceability matrices
• Create, review, and execute validation test scripts and protocols
• Support deviation management activities and issue resolution
• Prepare test summaries, validation reports, and compliance documentation
• Ensure validation activities meet quality and regulatory requirements
• Collaborate with business, quality, and technical teams throughout project delivery
• Support system releases and validation closeout activities

• Experience leading validation efforts within regulated environments
• Advanced knowledge of CSV methodologies and best practices
• Experience applying risk based validation approaches
• Experience developing and reviewing validation documentation
• Experience creating and managing Requirements Traceability Matrices
• Experience authoring and executing validation test scripts and protocols
• Experience managing deviations and validation findings
• Knowledge of GxP, data integrity, and compliance requirements
• Strong documentation and technical writing skills
• Strong communication and stakeholder management skills
• Ability to work onsite in Raritan, New Jersey 3 days per week

• Pharmaceutical or life sciences industry experience
• Quality Assurance experience
• Experience supporting regulated system implementations
• Experience with validation audits and inspections
• Experience supporting enterprise software validation initiatives

This role is ideal for a CSV professional who enjoys leading validation activities, supporting quality and compliance initiatives, and ensuring systems are delivered in accordance with regulatory and organizational standards.

The CSI Companies is a leading staffing and recruiting firm providing organizations with highly skilled professionals since 1994. We have been recognized as a Best of Staffing award winner for over a decade and pride ourselves on delivering exceptional talent nationwide.

• Medical dental and vision coverage
• Voluntary life and AD and D coverage
• Opportunity for advancement upon performance and availability