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Skills
Algorithmsunmatched
Analysis Skillsunmatched
Bioinformaticsunmatched
Bioinformatics Validation unmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Cloud Applicationsunmatched
Code of Federal Regulationsunmatched
Computer Systemsunmatched
Consultingunmatched
Data Analysisunmatched
Data Managementunmatched
Data Processingunmatched
Data Qualityunmatched
GMP (Good Manufacturing Practices)unmatched
Genomicsunmatched
GxPunmatched
Laboratory Systemsunmatched
Maintain Complianceunmatched
Next Generation Sequencing (NGS)unmatched
Process Validationunmatched
Python Programming/Scripting Languageunmatched
R Programming Languageunmatched
Risk Analysisunmatched
Science Softwareunmatched
Software Administrationunmatched
Software Upgradesunmatched
Software Validationunmatched
System Validationunmatched
Validation Planunmatched
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.