Computer System Validation - Senior Consultant - Life Sciences

EY • Pittsburgh, DC

22h • Hybrid

About The Position

At EY, we help clients succeed in a globally connected powerhouse of diverse teams and build a better working world. Our Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting their organization’s performance and patient safety. 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, 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.

Requirements

• 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
• 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.

Nice To Haves

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

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.

Benefits

• Comprehensive compensation and benefits package
• Rewarded based on your performance and recognized for the value you bring to the business
• 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 when needed to support your physical, financial, and emotional well-being

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees