Computer System Validation - Senior Consultant - Life Sciences

Chris Baily; New York (NY); Hybrid; USD 94,000 - 155,000; Full time

Benefits offered by this job

Healthcare benefits

Pension plan

401(k)

Hybrid work model

Job summary

EY Global Services is recruiting for a Life Sciences Risk Consulting professional in the New York area. The role focuses on defining, implementing, and maintaining CSV validation and assurance practices across GxP-regulated systems, ensuring data integrity and regulatory compliance throughout the lifecycle.

You will collaborate with business, quality, and technology stakeholders to align validation with development, implementation, and change activities, while supporting audit readiness and

Qualifications

• Bachelor's or master's degree in a related field with at least three years of experience.
• 3+ years in Life Sciences with GxP, risk management or compliance exposure.
• Experience validating MES/ERP systems and using Veeva Vaults, LIMS, or similar tools.

Responsibilities

• Lead computer systems validation activities to ensure GxP systems are fit for use and compliant.
• Define and apply risk-based validation and testing across the system lifecycle.
• Integrate validation with SDLC and delivery models while maintaining compliance.
• Own validation strategy scope, approach, and alignment with quality and delivery.
• Lead validation workstreams with timely execution and stakeholder alignment.
• Oversee validation documentation, traceability, and change management.
• Support data integrity, audit readiness, and ongoing regulatory compliance.

Skills

CSV validation

SDLC

Agile delivery

GxP regulatory knowledge

Data integrity understanding

Cross-functional collaboration

Documentation and communication

Team leadership

Education

Bachelor's or Master's in Computer Science / Biomedical Engineering / Quality Engineering / Manufacturing

Tools

MES

ERP systems

Veeva Vaults

LIMS

Validation Lifecycle Management Systems

Job description

Salary: $93,600 - $154,500
Job Function: Risk Consulting
Employer: EY Global Services
Locations: New York, Boston, Chicago, Hoboken, McLean, Pittsburgh, Philadelphia, Washington

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 to build a better working world. 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 impacting patient safety.

The opportunity

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.

Your key responsibilities

Your time will be spent supporting client engagement teams to deliver projects in the life sciences domain, including:

• 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%.

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.

To qualify for the role you must have

• 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.
• Ideally, you’ll also have Experience in validating and implementing MES and other ERP systems, Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems.

What we look for

We are interested in passionate leaders with strong delivery capability, and a strong desire to stay on top of trends in the life sciences industry. If you have a strong passion for helping businesses drive measurable value while serving patients, then this role is for you.

What we offer you

At EY, we’ll develop you with future-focused skills and equip you with world-class experiences. We’ll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn more. We offer a comprehensive compensation and benefits package where you’ll be rewarded based on your performance and recognized for the value you bring to the business. 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. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year. Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances. You’ll also be granted 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.

Are you ready to shape your future with confidence?

We accept applications for this position on an on-going basis.

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, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY’s Talent Shared Services Team (TSS) or email the TSS at [e-mail].