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.
