Computer System Validation - Senior Consultant - Life Sciences

Location

New York, Boston, Chicago, Pittsburgh, Hoboken, McLean, Philadelphia, Washington

The Life Sciences Risk Consulting Services team supports organizations operating in highly regulated environments, helping life sciences clients define, implement, and maintain computer systems validation (CSV) and assurance practices across GxP‑regulated systems. The role involves partnering with business, quality, and technology stakeholders to align validation strategy with system development, implementation, and change activities, and to support audit readiness and ongoing compliance with global regulatory requirements.

• Lead computer systems validation activities to ensure GxP‑regulated systems are fit for intended use and compliant with regulatory expectations.
• 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.
• Lead validation work streams within projects, ensuring timely execution, quality outcomes, and stakeholder alignment.
• Oversee validation documentation, traceability, and change management for validated systems.
• Support data integrity, audit readiness, and ongoing compliance across regulated systems.

• Strong grounding in CSV, SDLC, and Agile delivery models.
• Practical experience with risk‑based validation and testing methodologies.
• Solid understanding of GxP regulations, including 21 CFR Part 11, Annex 11, and data integrity guidance.
• Ability to translate regulatory expectations into pragmatic, scalable validation approaches.
• Experience working across manufacturing, quality, IT, and automation teams.
• Clear, structured communication and strong documentation skills.
• Effective teamwork with diverse skills and backgrounds.
• Fostering an innovative and inclusive team‑oriented work environment.
• Demonstrating deep technical capabilities and professional knowledge.

• A bachelor’s or master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing, or a related field and at least three years of related work experience.
• 3+ years of Life Sciences work experience, including experience with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs, or integration of risk management functions.

Experience in validating and implementing MES and other ERP systems, Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems.

We offer a comprehensive compensation and benefits package, including competitive base salary ranging from $93,600 to $154,500 across the U.S. (up to $175,600 in certain metro areas), medical and dental coverage, pension and 401(k) plans, and a range of paid time off options.

EY provides equal employment opportunities to all applicants and employees regardless of race, color, religion, age, sex, sexual orientation, gender identity or expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis. EY is committed to providing reasonable accommodation to qualified individuals with disabilities during the application and employment process.