CSV Consultant

Katalyst Talent Agency

Norwood, MA, United States

13 days ago

Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Working hours

Regular working hours

Job source

www.indeed.com

Tech stack

Data Analysis Bioinformatics Computational Biology Data Integrity Python (Programming Language) System Testing Automated Data Processing (ADP) Iq/oq/pq GXP

Job description

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.

Requirements

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.