The Senior Consultant in Computer System Validation will work within EY's Life Sciences Risk Consulting Services team, focusing on helping clients in highly regulated environments. This role involves defining, implementing, and maintaining computer systems validation practices across GxP-regulated systems. The consultant will partner with various stakeholders to ensure compliance with regulatory expectations and industry standards. The position emphasizes the importance of data integrity and audit readiness in supporting patient safety and business performance.

• A bachelor's or master's degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field.
• At least three years of related work experience in Life Sciences.
• Strong grounding in Computer System Validation (CSV), Software Development Life Cycle (SDLC), and Agile delivery models.
• Practical experience with risk-based validation and testing methodologies.
• Solid understanding of GxP regulations, including 21 CFR Part 11 and data integrity guidance.

• Lead computer systems validation activities to ensure GxP-regulated systems are fit for intended use.
• Define and apply risk-based validation and testing strategies across the system lifecycle.
• Ensure validation is effectively integrated with SDLC and delivery models while maintaining compliance.
• Establish and own the overall validation strategy, including scope, approach, and alignment with quality and delivery models.
• Oversee validation documentation, traceability, and change management for validated systems.

• Ernst & Young (EY) offers a comprehensive and competitive benefits package designed to support the well-being of its employees across various dimensions.