Computer System Validation - Senior Consultant - Life Sciences
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.
- 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
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.
- Support client engagement teams to deliver projects in the life sciences domain.
- Consistently deliver quality client services by demonstrating in-depth technical capabilities and professional knowledge.
- Maintain long-term client relationships.
Benefits
- medical and dental coverage
- pension and 401(k) plans
- a wide range of paid time off options
- flexible vacation policy
- designated EY Paid Holidays
- Winter/Summer breaks
- Personal/Family Care
- other leaves of absence
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What This Job Offers
Job Type
Full-time
Career Level
Senior
