CSA Validation Subject Matter Expert (SME

Job Title

Key Responsibilities

• Provide expertise and insight on validation project risk assessment and complexity.
• Maintain validation best practices and ensure alignment with Good Documentation Practices (GDP).
• Gather project information from System Owners and collaborate with Business Analysts.
• Draft, review, and execute key validation deliverables, including:
• GxP Assessment
• Risk Assessment (RA)
• Validation Plan (VP)
• Test Plan (TP)
• Validation Summary Report (VSR)
• Collect feedback from stakeholders and ensure regulatory and data integrity compliance.
• Contribute to the development and review of additional validation documentation as needed.
• Support change management and maintain documentation according to GAMP 5 and 21 CFR Part 11 standards.

Qualifications & Experience

• Bachelor’s Degree in Computer Science, IT, Chemical/Biomedical Engineering, or related field.
• 7–10+ years of progressive experience in Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Strong understanding of GxP, FDA regulations, Data Integrity, and ALCOA+ principles.
• Hands-on experience in CAPA generation, review, and resolution.
• Strong communication, leadership, and collaboration skills.
• Experience working in Medical, Pharmaceutical, or Regulatory Compliance industries is required.
• Agile experience/knowledge is highly preferred.