Computer System Validation (CSV) Specialist

Baim Institute for Clinical Research; Boston (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Baim Institute for Clinical Research seeks a CSV Specialist to ensure computerized systems are validated, compliant, and audited in line with FDA Part 11, GxP, and ALCOA+ principles. You will partner across IT, Clinical Operations, Data Management, and QA to uphold data integrity and lifecycle management for CTMS, EDC, and eTMF systems.

The role emphasizes risk-based validation, documentation, vendor assessments, and training to sustain regulatory readiness and continuous improvement.

Qualifications

• Bachelor’s degree or equivalent in a regulated field.
• 5+ years of CSV experience in regulated environments.
• Knowledge of FDA 21 CFR Part 11, GAMP 5, and ALCOA+.

Responsibilities

• Lead risk-based validation activities for GxP systems.
• Develop and maintain validation documentation (URS, specs, IQ/OQ/PQ, validation reports).
• Coordinate and execute validation testing per GAMP 5 and FDA expectations.
• Maintain validated systems through change control and lifecycle management.
• Serve as CSV SME during audits and regulatory inspections.

Skills

CSV expertise

GxP validation

Regulatory compliance

Data integrity

Audits & inspections

Education

Bachelor’s degree in IT/CS/Life Sciences/QA or related field

Tools

Microsoft 365

Azure

SharePoint Online

Teams

Purview

Log Analytics

Job description

The Computer System Validation (CSV) Specialist ensures computerized systems are validated, maintained, and operated in compliance with applicable regulatory requirements and industry best practices. The role serves as a subject matter expert in CSV, FDA 21 CFR Part 11, GxP, data integrity, and computerized system lifecycle management.

The CSV Specialist partners with IT, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Quality Assurance, and external sponsors to validate systems supporting clinical research and maintain regulatory compliance, data integrity, audit readiness, and risk management.

Computer System Validation

• Lead risk-based validation activities for GxP-regulated computerized systems.
• Develop and maintain validation documentation, including URS, specifications, risk assessments, traceability matrices, IQ/OQ/PQ protocols, and validation reports.
• Coordinate and execute validation testing in accordance with GAMP 5 and FDA expectations.
• Maintain validated systems through change control and lifecycle management.

Regulatory Compliance & Risk Management

• Ensure compliance with FDA 21 CFR Part 11, GxP, ALCOA+ principles, GDPR, HIPAA, ICH E6(R3), and sponsor requirements.
• Assess electronic records, electronic signatures, audit trails, system changes, and data integrity controls.
• Conduct system risk assessments and develop appropriate mitigation and remediation plans.

Cloud, SaaS & Microsoft Technologies

• Validate cloud-based, SaaS, and on-premises applications, including Microsoft 365, Azure, SharePoint, Teams, CTMS, EDC, eTMF, and QMS platforms.
• Review vendor validation packages and assess supplier compliance.
• Evaluate and support compliance controls using Microsoft Purview, Defender, Entra ID, Azure Monitor, and Log Analytics.

Clinical Research & Data Integrity

• Validate systems supporting clinical research, including CTMS, EDC, eTMF, safety, statistical, and reporting systems.
• Ensure data is accurate, complete, consistent, reliable, and traceable.
• Support data governance, audit trail monitoring, record retention, and regulatory compliance.

Audits, Documentation & Training

• Serve as the CSV subject matter expert during sponsor audits, regulatory inspections, quality audits, and vendor assessments.
• Provide validation and compliance documentation and support corrective actions.
• Develop validation procedures, work instructions, and templates.
• Train employees on validation and system compliance requirements.

Qualifications

Education

• Bachelor’s degree in information technology, Computer Science, Life Sciences, Quality Assurance, or a related field, or equivalent experience in a regulated industry.

Experience

• 5+ years of Computer System Validation experience in pharmaceutical, biotechnology, medical device, clinical research, healthcare technology, or a related regulated environment.
• Demonstrated experience validating GxP-regulated systems and supporting audits and regulatory inspections.

Required Knowledge & Skills

• FDA 21 CFR Part 11, GAMP 5, GxP, CSV methodologies, and risk-based validation.
• ALCOA+ data integrity principles, electronic records/signatures, audit trails, SDLC, change management, and quality systems.
• Microsoft 365, Microsoft Purview, SharePoint Online, Teams, Azure/Log Analytics, and data governance technologies.

Preferred Certifications

• CSV, CQA, ASQ, GAMP, CISA, or CIPP certification/training.