CSV Consultant

Creative Solutions Services, LLC; Norwood (MA); On-site; USD 100,000 - 135,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Computer System Validation (CSV) Consultant to support a biotech client in validating bioinformatics software and data analysis platforms within a GMP-regulated environment in Norwood, MA.

Responsibilities include developing and executing Validation Plans, URS, IQ/OQ/PQ, and Validation Summary Reports, validating algorithms and data pipelines, and ensuring compliance with GAMP 5 and 21 CFR Part 11 through cross‑functional collaboration.

Qualifications

• Experience 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.

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

CSV in pharma/biotech

GxP validation

Bioinformatics workflows

Python/R data analysis

GAMP 5 & 21 CFR Part 11

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.

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.