Computer System Validation - Senior Consultant - Life Sciences

Location

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

The Life Sciences Risk Consulting Services team supports organizations operating in highly regulated environments where validated systems, reliable data, and regulatory compliance are critical to business performance and patient safety. In this role, you will work with life sciences clients to define, implement, and maintain computer systems validation (CSV) and assurance practices across GxP‑regulated systems.

You will help clients establish risk‑based validation approaches aligned with regulatory expectations and industry standards, ensuring systems are fit for intended use throughout their lifecycle. This includes supporting validation activities across quality, laboratory, manufacturing, and enterprise platforms, and ensuring data integrity across integrated system landscapes.

The role involves partnering with business, quality, and technology stakeholders to align validation strategy with system development, implementation, and change activities, while supporting 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.
• Maintain long‑term client relationships and deliver quality client services by demonstrating in‑depth technical capabilities and professional knowledge.

• 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.
• Effectively working on teams 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 working 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.

• Comprehensive compensation and benefits package: base salary range $93,600 to $154,500 for U.S. locations; $112,400 to $175,600 for New York City metro area, Washington State and California (excluding Sacramento). Packaging may vary.
• Medical and dental coverage, pension and 401(k) plans, and a range of paid time off options.
• Hybrid work model: 40‑60% in‑person client engagement.
• Flexible vacation policy allowing employees to determine vacation based on personal circumstances; includes EY paid holidays, winter/summer breaks and other leaves.

EY provides equal employment opportunities to applicants and employees without regard to 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, including arrest and conviction records, in accordance with applicable law.

EY is committed to providing reasonable accommodation to qualified individuals with disabilities, including veterans with disabilities. If you have a disability and need assistance applying online or an accommodation, please call 1‑800‑EY‑HELP3, select Option 2 for candidate related inquiries, then Option 1 for candidate queries and finally Option 2 for candidates with an inquiry which will route you to EY’s Talent Shared Services Team (TSS) or email the TSS at