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CSV Consultant

Karwell Technologies

Norwood, MA

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JOB DETAILS
SKILLS
Algorithms, Analysis Skills, Bioinformatics, Bioinformatics Validation , Biology, Biotech and Pharmaceutical, Change Control, Cloud Applications, Code of Federal Regulations, Computer Systems, Consulting, Data Analysis, Data Management, Data Processing, Data Quality, GMP (Good Manufacturing Practices), Genomics, GxP, Laboratory Systems, Maintain Compliance, Next Generation Sequencing (NGS), Process Validation, Python Programming/Scripting Language, R Programming Language, Risk Analysis, Science Software, Software Administration, Software Upgrades, Software Validation, System Validation, Validation Plan
LOCATION
Norwood, MA
POSTED
Today
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.

About the Company

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Karwell Technologies