What are the responsibilities and job description for the Computer System Validation Consultant position at Fusion Life Sciences Technologies LLC?
Job Title: Computer System Validation Consultant
Location: Boston, MA
Duration: 6 Months (Extended)
Project Overview:
Our client 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 Validation Summary Reports.
Validate scientific algorithms and automated data processing workflows to ensure accuracy and reproducibility.
Support implementation and upgrades of laboratory software, genomic analysis platforms, and cloud-based applications.
Collaborate with cross-functional teams to ensure systems meet regulatory and data integrity requirements.
Review software changes, perform impact assessments, and support change control activities.
Ensure compliance with GAMP 5, 21 CFR Part 11, and internal CSV standards.
Preferred Experience:
Computer System Validation (CSV) within the pharmaceutical or biotechnology industry.
Experience validating laboratory or scientific software in a GxP environment.
Familiarity with bioinformatics, genomics, Next Generation Sequencing (NGS), or computational biology workflows.
Understanding of scientific algorithms, automated data analysis, or Python/R-based pipelines.
Knowledge of GAMP 5, 21 CFR Part 11, and data integrity principles.
Experience working with Quality, IT, Bioinformatics, and Laboratory teams.