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CSV Consultant

Katalyst Healthcares & Life Sciences
  • Philadelphia, PA
  • Instant Apply
30+ days ago

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.

Numbers & Facts

LocationPhiladelphia, PA

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

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