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Katalyst Healthcares & Life Sciences

CSV Consultant

Pay: Not specified
Posted: 3 weeks ago
Location: Philadelphia, PA (Onsite)
Last Updated: 3 weeks ago
Hours: Full-Time
Expires: 10/6/2026
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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.
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.