Computer System Validation - Senior Consultant - Life Sciences

About EY-Parthenon•Boston, NY

1d•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.
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.