CSV Consultant

Katalyst Talent Agency
Norwood, United States of America
9 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English

Job location

Norwood, United States of America

Tech stack

Data analysis
Bioinformatics
Computational Biology
Data Integrity
Python
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.

Apply for this position