Job Description

The opportunity

We are looking for a proactive and detail-oriented Staff Consultant to support Computerized System Validation (CSV) initiatives across global pharmaceutical clients. This role offers hands-on experience with validated systems such as Veeva Vault QMS, TrackWise, SAP, LIMS, ELN, MES, and Regulatory Information Management Systems (RIMS). You’ll contribute to validation activities, system assessments, and compliance programs while collaborating with cross-functional teams in a regulated environment.

Your key responsibilities

  • Contribute to CSV activities using GAMP 5 Life Cycle methodology.

  • Support gap assessments and remediation for legacy systems to align with current validation policies.

  • Assist in software classification, IT risk assessments, and mitigation planning.

  • Troubleshoot application-related issues and recommend solutions in collaboration with QA, IT, and business teams.

  • ...

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