CSV Consultant

Roles & Responsibilities

• Validate bioinformatics software and data analysis systems.
• Develop and execute Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Summary Reports.
• 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.

Preferred Experience

• Computer System Validation (CSV) in Pharmaceutical/Biotechnology environments.
• Validation of laboratory or scientific software in GxP environments.
• Bioinformatics, Genomics, NGS, or Computational Biology workflows.
• Scientific algorithms and Python/R-based data analysis pipelines.
• Strong knowledge of GAMP 5, 21 CFR Part 11, and data integrity principles.
• Experience collaborating with Quality, IT, Bioinformatics, and Laboratory teams.