Computer System Validation - Senior Consultant - Life Sciences

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

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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.

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.

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? Apply today.

EY accepts applications for this position on an on-going basis.

For those living in California, please click here for additional information.

EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities.

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