The Senior Consultant in Computer System Validation will work within EY's Life Sciences Risk Consulting Services team, focusing on ensuring compliance and performance in highly regulated environments. This role involves collaborating with clients to define and implement computer systems validation practices across GxP-regulated systems. The consultant will establish risk-based validation approaches aligned with regulatory expectations and industry standards. The position requires strong communication and teamwork skills to foster an innovative and inclusive work environment.

• 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.
• 3+ years of experience with Life Science regulatory statutes, GxP business processes, or system validations.
• 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 and approach.
• 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.