Senior CSV Lead – Life Sciences (Regulated Systems)

Ernst & Young Advisory Services Sdn Bhd

New York (NY)

Hybrid

USD 112,000 - 176,000

Full time

14 days+

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Job summary

EY in New York seeks a Life Sciences Validation Consultant to help define, implement, and maintain computer systems validation (CSV) and validation assurance across GxP-regulated environments for life sciences clients.

You will collaborate with business, quality, and IT teams to align validation with regulatory expectations, support audit readiness, ensure data integrity, and drive system lifecycle activities across manufacturing, quality, and enterprise platforms.

Qualifications

Bachelor’s or master’s degree in a related field with at least three years of work experience.
3+ years Life Sciences work experience in regulatory or GxP contexts.

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 integrated with SDLC and delivery models while maintaining compliance.
Establish and own the overall validation strategy, including scope 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.