Computer System Validation - Senior Consultant - Life Sciences

EY; Hoboken (NJ); Hybrid; USD 93,600 - 154,500; Full time

Benefits offered by this job

Base salary range

Medical & dental coverage

Hybrid work model

Paid time off

Job summary

EY in the United States seeks a Life Sciences Risk Consulting professional to lead computer systems validation (CSV) activities in GxP environments. You will define risk-based validation strategies, align with SDLC and QA, and partner with business, quality, and IT to ensure data integrity and audit readiness.

Travel up to 40% is required; a life sciences background with 3+ years of regulatory or validation experience is essential.

Qualifications

• 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.

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.

Skills

CSV expertise

SDLC

Agile delivery

Regulatory compliance

GxP regulations

Communication

Education

Bachelor's or Master's in CS/Engineering

Tools

MES

ERP systems

Veeva Vaults

LIMS

Validation lifecycle management

Job description

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

Overview

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help build a better working world.

The Opportunity

Our clients operate in a world where achieving high performance is just as important as the patients they serve. EY’s 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.

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.

Full‑time employment; travel required up to 40%.

You will also be expected to 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 work on teams with diverse skills and backgrounds.
• Foster an innovative and inclusive team‑oriented work environment.
• Demonstrate deep technical capabilities and professional knowledge.

Qualifications

• 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.

Preferred Experience

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

Benefits

• Comprehensive compensation and benefits package with a base salary range of $93,600 to $154,500 (US) and higher ranges for certain metro areas.
• Medical and dental coverage, pension and 401(k) plans, and paid time off.
• Hybrid work model with 40‑60% in‑office expectations.
• Flexible vacation policy with paid holidays and personal/family care leave.

Equal Employment Opportunity

EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/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 either need assistance applying online or need to request an accommodation during any part of the application process, please call 1‑800‑EY‑HELP3.