GMP CSV Consultant for Bioinformatics & Genomics Validation

Katalyst CRO; Norwood (MA); On-site; USD 165,000 - 248,000; Full time

Job summary

Katalyst CRO is seeking 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.

You will develop and execute Validation Plans, IQ/OQ/PQ protocols, risk assessments, and Validation Summary Reports, ensuring compliance with GAMP 5 and 21 CFR Part 11, and collaborating with Quality, IT, Bioinformatics, and Laboratory teams.

Qualifications

• Experience validating bioinformatics software in GMP/GxP environments.
• Strong background in Computer System Validation (CSV) within pharmaceutical/biotechnology settings.
• Familiarity with GAMP 5 and 21 CFR Part 11 data integrity requirements.
• Experience with Python/R-based data analysis pipelines and computational biology workflows.

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, 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.

Skills

CSV validation in Pharma/Biotech

GxP compliance

Bioinformatics workflows

Genomics/NGS data analysis

Python/R pipelines

GAMP 5 & 21 CFR Part 11

Cross-functional collaboration

Job description

Katalyst CRO is seeking 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.

You will develop and execute Validation Plans, IQ/OQ/PQ protocols, risk assessments, and Validation Summary Reports, ensuring compliance with GAMP 5 and 21 CFR Part 11, and collaborating with Quality, IT, Bioinformatics, and Laboratory teams.