CSV Consultant

Katalyst CRO; Philadelphia (Philadelphia County); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking an experienced CSV Consultant to support a leading biotech client in validating bioinformatics software and data analysis platforms within a GMP-regulated environment.

The role focuses on developing validation plans, IQ/OQ/PQ protocols, and validation reports while ensuring compliance with GAMP 5 and 21 CFR Part 11. Collaboration with Quality, IT, and Bioinformatics teams is essential.

Qualifications

• Experience in CSV within pharma/biotech environments.
• Validation of lab/scientific software in GxP environments.
• Knowledge of bioinformatics workflows and data integrity principles.
• Experience with validated data analysis pipelines and algorithms.

Responsibilities

• Validate bioinformatics software and data analysis systems.
• Develop and execute Validation Plans, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Validate scientific algorithms and automated data processing workflows.
• Support laboratory software and genomic analysis platforms, including cloud apps.
• Perform impact assessments and assist change control activities.
• Ensure compliance with GAMP 5, 21 CFR Part 11 and data integrity.

Skills

CSV compliance

GxP validation

Quality liaison

Regulatory knowledge

Tools

Python

R

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.