Computer System Validation Specialist

ClinLab Solutions Group; United States; On-site; USD 75,000 - 110,000; Full time

Job summary

ClinLab Solutions Group is seeking a meticulous Software Tester to support validation and testing of clinical trial and healthcare software platforms. This role ensures systems meet regulatory standards, data integrity, and reliable clinical outcomes.

You will develop validation plans, execute IQ/OQ/PQ, perform manual and automated testing of APIs and integrations, and maintain mandatory documentation. The position requires 3+ years in healthcare testing and familiarity with FDA 21 CFR Part 11,

Qualifications

• 3+ years of software testing experience, preferably in healthcare or clinical trials.
• Experience validating regulated systems and documentation (CSV, IQ/OQ/PQ).

Responsibilities

• Develop and execute validation test plans and scripts for clinical systems.
• Perform manual and automated testing of EMAW ePRO/eCOA platform, APIs and data integrations.
• Ensure compliance with FDA, ICH E6 (R2), and HIPAA.
• Validate data integrity, audit trails, and electronic signatures.
• Create and maintain validation documentation (URS, FS, DS, RTM, validation summary reports).
• Identify, document, track defects; support CAPA and root cause analysis.
• Collaborate with product, engineering, and clinical operations teams to ensure testable requirements.
• Support system audits and inspections with traceability and validation evidence.
• Conduct risk-based testing and impact assessments for system changes.
• Participate in Agile development cycles while maintaining compliance documentation.

Skills

SDLC understanding

CSV validation

Regulatory/compliance awareness

Documentation practices

Data validation

Attention to detail

Education

Bachelor's degree in Computer Science, Life Sciences, or related field

Tools

Jira

SQL

Job description

We are seeking a meticulous and quality-driven Software Tester to support the validation and testing of clinical trial and healthcare software platforms. This role plays a critical part in ensuring systems meet regulatory standards, maintain data integrity, and support accurate, reliable clinical outcomes.

About the Role

The ideal candidate has experience testing regulated systems (e.g., eClinical platforms) and understands compliance requirements such as FDA 21 CFR Part 11, GxP, and HIPAA.

Responsibilities

• Develop and execute validation test plans, IQ/OQ/PQ protocols, and test scripts for clinical systems
• Perform manual and automated testing of the EMAW ePRO/eCOA platform, APIs and data integrations
• Ensure compliance with regulatory and quality standards (e.g., FDA, ICH E6 (R2))
• Validate data integrity, audit trails, and electronic signatures
• Create and maintain validation documentation (URS, FS, DS, RTM, validation summary reports)
• Identify, document, and track defects; support root cause analysis and corrective actions (CAPA)Collaborate with product, engineering, and clinical operations teams to ensure requirements are testable and compliant
• Support system audits and inspections by providing traceability and validation evidence
• Conduct risk-based testing and impact assessments for system changes
• Participate in Agile development cycles while maintaining compliance documentation

Qualifications

• Bachelor’s degree in Computer Science, Life Sciences, or related field
• 3+ years of experience in software testing, preferably in healthcare or clinical trials

Required Skills

• Strong understanding of Software Development Lifecycle (SDLC) and Computer System Validation (CSV)
• Hands-on experience with validation documentation and regulated environments
• Familiarity with clinical data standards and workflows
• Experience with tools such as Jira or similar
• Strong knowledge of SQL for data validation
• Excellent attention to detail and documentation skills

Preferred Skills

• Knowledge of regulatory requirements in clinical trials