CSV Consultant

Indotronix UK; Norwood (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Moderna is seeking a Computer System Validation (CSV) Consultant to support validation of bioinformatics software, data analysis platforms, and scientific algorithms in a GMP-regulated environment.

This role will ensure computerized systems are implemented and maintained in compliance with FDA regulations, GAMP 5, and 21 CFR Part 11, partnering with Bioinformatics, IT, Quality, and Laboratory teams in Norwood, MA.

Qualifications

• 4–7 years of CSV/CSV-like validation experience.
• Experience validating bioinformatics software and data analysis systems.

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.

Skills

change control

URS

risk assessments

IQ/OQ/PQ protocols

21 CFR Part 11

GAMP 5

validation plans

automated data processing workflows

laboratory software

genomic analysis platforms

pharmaceutical or biotechnology

Job description

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