Lead CSV Consultant, Life Sciences & Compliance

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

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