CSV Consultant: Bioinformatics & GMP Validation Specialist
Katalyst-Healthcares-
Summary: 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. 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. 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. 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. #J-18808-Ljbffr Katalyst-Healthcares-
Vacancy posted 11 hours ago
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