Computer System Validation Consultant

Job overview

The Computer System Validation Consultant role is onsite in Norwood, MA. Compensation is not specified. Katalyst Healthcares & Life Sciences is recruiting for work supporting a leading biotech client in a GMP-regulated environment. The consultant validates bioinformatics software, scientific algorithms, and data-analysis platforms so laboratory and scientific systems operate in compliance with applicable quality and data-integrity requirements. The work supports reliable, controlled use of software and automated workflows in regulated settings.

What you'll do

• 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 application implementations or upgrades
• perform impact assessments
• support change control
• and ensure compliance with GAMP 5, 21 CFR Part 11, and data-integrity requirements.

What we're looking for

Skills & competencies

computer system validation

csv consultant

bioinformatics

gmp

gamp 5

21 cfr part 11

laboratory software

norwood ma

katalyst healthcares & life sciences

Work arrangement

• Weekend coverage required

Why this role

Preferred experience includes CSV in pharmaceutical or biotechnology environments, GxP laboratory software, bioinformatics or genomics workflows, Python/R pipelines, and collaboration with Quality, IT, Bioinformatics, and Laboratory teams.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.