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# CSV Engineer (GxP Systems Engineer)

- **Company:** Intellectt, Inc
- **Location:** Norwood, MA, United States
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, Audit Trail, Data Integration, Document Management Systems, Fourier Transform Infrared Spectroscopy, Network Troubleshooting, Machine Learning, Systems Development Life Cycle, Chromeleon, System Testing, Iq/oq/pq, Enterprise Software Applications, GXP, Servicenow
- **Published:** June 23, 2026
- **Apply:** https://www.careerjet.com/jobad/use44b1ab94f7869a6e314c8fefe4c5eb2

## About the Role

* Bachelor's degree in STEM (or related field)
 * 4+ years in cGxP environment
 * Experience with CSV documentation and lifecycle activities
 * Familiarity with QMS, Document Management, ServiceNow
 * Experience with KNEAT or similar SDLC tools
 * Knowledge of change controls, deviations, and CAPA processes

Preferred Skills:

 * Experience with lab instruments (TOC, Bioanalyzers, Spectramax)
 * Experience with systems like Chromeleon, LabX
 * Background in pharma/biotech or regulated industries
 * Experience with data integration and lab connectivity
 * Strong communication and ability to work cross-functionally.

## Description

* Manage lifecycle of lab systems (HIAC, FTIR, TOC, Bioanalyzers, Sequencers) and enterprise systems (Chromeleon, LogiLab, SoftMax Pro).
 * Translate business and technical requirements into digital lab system solutions.
 * Lead and execute Computer System Validation (CSV) activities (URS, FRS, IQ/OQ/PQ, etc.).
 * Author and maintain validation and compliance documentation.
 * Act as system administrator for QC lab systems.
 * Troubleshoot system issues and support incident resolution.
 * Conduct periodic reviews, audit trail reviews, and user access reviews.
 * Ensure GMP compliance and inspection readiness.


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