Computer System Validation Engineer

The Computer System Validation Engineer is responsible for ensuring that computerized systems used across the organization are validated, maintained, and compliant with applicable regulatory requirements and internal policies. This role supports both GxP regulated systems and non-GxP systems that may store, process, or transmit PHI and sensitive clinical data.

The CSV Engineer partners with Quality Assurance, Information Technology, Clinical Operations, and Business Stakeholders to ensure computerized systems remain fit for their intended use throughout their lifecycle while maintaining data integrity, security, and regulatory compliance.

How You'll Make An Impact

• Plan, execute, and maintain validation activities for computerized systems in accordance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and applicable GxP regulations.
• Develop and maintain validation documentation including:
• Validation Plans
• User Requirements Specifications (URS)
• Functional Specifications (FS)
• Risk Assessments
• Test Cases
• Traceability Matrices
• Validation Summary Reports
• Perform system risk assessments to determine validation scope and testing requirements.
• Ensure systems remain in a validated state through periodic reviews, change control, and lifecycle management.
• Review software releases, upgrades, patches, and configuration changes for validation impact.
• Develop standard operating procedures (SOPs), work instructions, and validation templates.
• Participate in regulatory inspections, customer audits, and internal quality audits.

The Expertise Required

• Strong knowledge of GAMP 5 guidelines, FDA 21 CFR Part 11, ICH E6(R3) Good Clinical Practice, EU CTR 536/2014, data integrity rules, and software development life cycles.
• Highly organized and able to manage multiple priorities in a fast-paced environment.

Certifications/Licenses, Education, and Experience

• Minimum Education:
• Minimum high school diploma or GED required.
• Prefer a degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience.
• Minimum Experience:
• 4+ years of direct CSV experience in a regulated life sciences or clinical research field.
• Hands-on experience with the validation of life sciences/clinical applications (e.g., QMS, CTMS, LIMS, eSource, eBinder).