CSV Quality Support Lead

CSI Companies; New Jersey; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Voluntary life & AD&D coverage

Career advancement

Job summary

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

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

Qualifications

• Experience leading validation in 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.

Responsibilities

• Lead and execute CSV 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 and data integrity.
• 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 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.
• Support system releases and validation closeout.

Skills

CSV validation

Regulated environment leadership

Risk-based validation

Documentation writing

Testing & protocols

Deviation management

GxP knowledge

Stakeholder management

onsite collaboration

Tools

Requirements Traceability Matrix

Job description

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 workstreams, 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

Work Authorization

• 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.

What you will do

• 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

What we are looking for

• 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

Nice to have

• 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

Who Should Apply

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.

About Us

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.

Benefits Offered

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