Computer System Validation - Staff Consultant - Life Sciences

EY•Pittsburgh, DC

2d•$73,900 - $138,500•Hybrid

About The Position

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

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.
1–2 years of life sciences experience, including exposure to regulatory requirements, GxP business processes, system validation, risk management, compliance programs, or integration of risk management functions.
Willingness and ability to travel as needed to meet client service requirements.
Ability to work in a flexible environment, including client sites, EY offices, and virtual settings.
A valid driver’s license and access to reliable transportation.
Ability to support domestic and, as needed, international travel; A valid passport is required or the ability to obtain one.
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
Demonstrating technical capabilities and professional knowledge

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

Support computer systems validation (CSV) activities to help ensure GxP‑regulated systems are fit for intended use and compliant with regulatory expectations.
Execute validation and testing activities using established risk‑based strategies across the system lifecycle.
Assist in integrating validation activities within SDLC and delivery models while maintaining compliance with defined standards.
Contribute to validation planning by supporting development of scope, approach, and alignment with quality and delivery models.
Support project workstreams by executing assigned validation tasks, meeting timelines, and coordinating with team members.
Prepare and maintain validation documentation, ensuring traceability and supporting change management for validated systems.
Assist with data integrity efforts, audit readiness activities, and ongoing compliance across regulated systems.
Work as part of a team to consistently deliver quality client services by applying technical knowledge, following established methodologies, and supporting the development of client relationships.