CSV Consultant
Katalyst Healthcares & Life SciencesRapid City, SD
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.1
Reclaim your time by letting our AI handle the grunt work of job searching.
We continuously scan millions of openings to find your top matches.
Overview
Remote
On-site
Job Description
Summary: 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.
- 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.
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
FAQs About CSV Consultant Jobs at Katalyst Healthcares & Life Sciences
What is the work location for this position at Katalyst Healthcares & Life Sciences?
This job at Katalyst Healthcares & Life Sciences is located in Rapid City, SD, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
What employment applies to this position at Katalyst Healthcares & Life Sciences?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Katalyst Healthcares & Life Sciences?
You can apply for this role at Katalyst Healthcares & Life Sciences either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.