> Markdown version of [/jobs/ext/2293120-csv-and-validation-engineer](https://www.wearedevelopers.com/jobs/ext/2293120-csv-and-validation-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# CSV and Validation Engineer

- **Company:** Katalyst Talent Agency
- **Location:** United States
- **Contract:** Permanent contract
- **Skills:** JIRA, Audit Trail, Data Integrity, Middleware, Laboratory Information Management Systems, Requirements Traceability, System Testing, Systems Integration, Iq/oq/pq, Information Technology, Trackwise, Veeva, GXP
- **Published:** August 29, 2026
- **Apply:** https://www.dice.com/job-detail/9669873a-0233-4ba0-9298-0e7656fffb46

## About the Role

* 5 to 10+ years in CSV/validation within regulated labs or life sciences.
 * Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5.
 * Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports.
 * Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware.
 * Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise.
 * Excellent technical writing, organization, and cross- functional communication.

## Description

We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs.
Responsibilities:

 * Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5.
 * Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports.
 * Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails.
 * Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
 * Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections.
 * Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
 * Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates.


## Related Videos

- [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture)
- [Improving quality with Agentic AI with Rovo Dev and Xray](https://www.wearedevelopers.com/videos/2005-improving-quality-with-agentic-ai-with-rovo-dev-and-xray)
- [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer)
- [Enabling automated 1-click customer deployments with built-in quality and security](https://www.wearedevelopers.com/videos/83-enabling-automated-1-click-customer-deployments-with-built-in-quality-and-security)
- [Collaboration Quantified: Lessons from Open Source Developer Networks](https://www.wearedevelopers.com/videos/1422-collaboration-quantified-lessons-from-open-source-developer-networks)
- [Integrate your Cognitive Assistant with 3rd-party DBs and software](https://www.wearedevelopers.com/videos/249-integrate-your-cognitive-assistant-with-3rd-party-dbs-and-software)

## Related Articles

- [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again)
- [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools)
- [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers)
- [Dev Digest 121 - AI goes offline](https://www.wearedevelopers.com/magazine/456-dev-digest-121-ai-goes-offline)
- [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development)
- [Quick guide: How to write a Software Developer CV](https://www.wearedevelopers.com/magazine/37-quick-guide-how-to-write-a-software-developer-cv)