CSV Consultant

About the role

We're looking for an experienced Computer System Validation (CSV) Consultant to support a leading biotech client in validating bioinformatics software, scientific algorithms, and data analysis platforms within a GMP-regulated environment.

Responsibilities

• Validate bioinformatics software and data analysis systems.
• Develop and execute Validation Plans, Risk Assessments, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Validation Summary Reports.
• Validate scientific algorithms and automated data processing workflows.
• Support laboratory software, genomic analysis platforms, and cloud‑based application implementations/upgrades.
• Perform impact assessments and support change control activities.
• Ensure compliance with GAMP 5, 21 CFR Part 11, and data integrity requirements.

Requirements

• Experience in Computer System Validation (CSV) within Pharmaceutical or Biotechnology environments.
• Validation of laboratory or scientific software in GxP environments.
• Familiarity with bioinformatics, genomics, NGS, or computational biology workflows.
• Experience with scientific algorithms and Python/R‑based data analysis pipelines.
• Strong knowledge of GAMP 5, 21 CFR Part 11, and data integrity principles.
• Proven ability to collaborate with Quality, IT, Bioinformatics, and Laboratory teams.