CSV Consultant

Katalyst Healthcares & Life Sciences

🇺🇸 United States

On-site

Mid level

4 weeks ago

GMP
GxP
NGS
Python

4 weeks ago

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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.

CSV Consultant · Katalyst Healthcares & Life Sciences

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