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Katalyst Healthcares & Life Sciences

CSV Consultant

Pay: Not specified

Posted: 5 weeks ago

Location: Rapid City, SD (Onsite)

Last Updated: 5 days ago

Hours: Full-Time

Expires: 11/13/2026

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Job Description

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.

Requirements:

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.