CSV Consultant

Katalyst-Healthcares-; Rapid City (SD); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced 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 Validation Plans, IQ/OQ/PQ, risk assessments, and validation reports, validate data processing workflows, and ensure compliance with GAMP 5 and 21 CFR Part 11 while collaborating with Quality, IT, Bioinformatics, and Laboratory teams.

Qualifications

• Experience with CSV in Pharmaceutical/Biotechnology environments.
• Validation of laboratory or scientific software in GxP environments.
• Experience with bioinformatics, genomics, NGS, or computational biology workflows.
• Experience with scientific algorithms and Python/R-based data analysis pipelines.
• Strong knowledge of GAMP 5, 21 CFR Part 11, and data integrity.

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.

Skills

Computer System Validation in pharma/β

Bioinformatics workflows

Python/R data analysis

GAMP 5 compliance

21 CFR Part 11 compliance

Data integrity

Cross-functional collaboration

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.