Senior Computer System Validation Analyst (CSV Lead)

About the role

We are looking for a highly experienced Computer System Validation (CSV) Lead to ensure our computer systems meet FDA and other regulatory requirements. The role involves overseeing validation activities for systems used in development, manufacturing, and distribution of regulated products.

Key responsibilities

• Lead the end‑to‑end CSV lifecycle, from planning through execution, documentation and approvals.
• Develop, review and maintain validation deliverables such as plans, protocols, risk assessments, traceability matrices and final reports.
• Collaborate with IT, quality, compliance, vendors and business stakeholders to define validation strategies.
• Conduct risk assessments, impact analyses and design validation testing (IQ, OQ, PQ, UAT).
• Provide guidance, training and subject‑matter expertise on CSV best practices.
• Support audits, inspections and continuous improvement of the CSV program.

Required profile

• Bachelor’s degree in Computer Science, Engineering or related field (advanced degree a plus).
• Minimum 3 years of experience in FDA‑regulated environments with a focus on computer system validation.
• Strong knowledge of 21 CFR Part 11, 21 CFR Part 820 and GAMP standards.
• Proven ability to lead CSV activities for complex systems.
• Excellent written and verbal communication skills.

Required skills

• Computer System Validation (CSV)
• Risk Assessment
• Validation Testing (IQ, OQ, PQ, UAT)
• Software Development Life Cycle (SDLC)
• Agile methodology
• Waterfall methodology
• Laboratory Information Management System (LIMS)
• Electronic Data Capture (EDC) systems
• Manufacturing Execution System (MES)
• GAMP