Computer System Validation - Senior Consultant - Life Sciences

About the role

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, industry standards, and system delivery models, 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.

Your Key Responsibilities

• 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 workstreams 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.
• Work on teams to consistently deliver quality client services by demonstrating in-depth technical capabilities and professional knowledge, and maintaining long-term client relationships.

Skills And Attributes For Success

• 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

Requirements

• 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
• 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

Qualifications

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

Benefits

• Comprehensive compensation and benefits package with rewards based on performance and recognized value
• Medical and dental coverage
• Pension and 401(k) plans
• Wide range of paid time off options
• Flexible vacation policy
• Time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence

Pay

The base salary range for this job in all geographic locations in the US is $93,600 to $154,500. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $112,400 to $175,600. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography.

Schedule

Full time employment with travel required up to 40%. Team-led and leader-enabled hybrid model with an expectation of 40–60% in-person collaboration over the course of an engagement, project or year.