Senior CSV Consultant: Life Sciences, Hybrid

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

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.