CSV Specialist: Regulatory System Validation & Compliance

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

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.