CSV Consultant
Listed on 2026-08-01
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IT/Tech
IT Consultant, Data Scientist
Project Overview
Moderna is seeking a Computer System Validation (CSV) Consultant to support the validation of bioinformatics software, data analysis platforms, and scientific algorithms used in a GMP-regulated environment. This individual will ensure computerized systems are implemented and maintained in compliance with FDA regulations, GAMP 5, and 21 CFR Part 11 while partnering with Bioinformatics, IT, Quality, and Laboratory teams.
Key Responsibilities- Perform validation of bioinformatics software and data analysis systems.
- Develop and execute validation documentation including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and V...
City
[Norwood, MA], United States
Experience
4 - 7 Years
Primary Skills
change control, URS, risk assessments, IQ/OQ/PQ protocols, 21 CFR Part 11, GAMP 5, validation plans, and internal CSV standards, automated data processing workflows, laboratory software, genomic analysis platforms, pharmaceutical or biotechnology
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