CSV Consultant

Creative Solutions Services, LLC; Philadelphia (Philadelphia County); On-site; USD 120,000 - 160,000; Full time

Job summary

Creative Solutions Services, LLC 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, Risk Assessments, URS, IQ/OQ/PQ, and Validation Summary Reports, validate automated data workflows, and ensure compliance with GAMP 5 and FDA data integrity standards.

Qualifications

• Experience validating CSV in GMP-regulated environments.
• Experience validating laboratory or scientific software in GxP environments.
• Knowledge of GAMP 5 and data integrity principles.

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 applications.
• Perform impact assessments and support change control activities.
• Ensure compliance with GAMP 5, 21 CFR Part 11, and data integrity requirements.

Skills

CSV in Pharma/Biotech

GxP environments

Bioinformatics workflows

Python/R data analysis

GAMP 5/21 CFR Part 11

Quality/IT collaboration

Tools

IQ/OQ/PQ execution

Validation Plans/Reports

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.