Job-ID Reference 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.
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.
CSV Consultant in philadelphia at Unknown Company
This position is listed as full time and onsite.