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# CSV Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Somerville, NJ, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** JIRA, Data Infrastructure, Systems Development Life Cycle, Test Scripts, Atlassian Tools, GXP
- **Published:** November 5, 2026
- **Apply:** https://www.thejobnetwork.com/job/104cfd07-b5c5-444e-9835-09b29ad78a30/csv-engineer

## About the Role

* Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience.
 * Proven experience with Manufacturing, MES, and Data Platform Applications, including support for global and regional GxP computerized systems.
 * Deep knowledge of GxP compliance, FDA/Global regulations, and Inspection Readiness.
 * Expertise in validation documentation and deliverables, including review of compliance plans, requirements, design specs, test protocols, test scripts, defects, traceability, reports and system procedures.
 * Demonstrated application of risk-based validation and risk management practices.
 * Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants).
 * Strong project coordination and stakeholder communication skills, including managing risks, issues, and status reporting.
 * " Experience in writing documentation (i.e. Compliance Plan, Test Plans, Test Reports, Compliance Summary Reports, and SOPs).
 * Knowledge of Agile Tools (e.g., Jira, Xray, qTest, etc.).
 * Ability to build collaborative partnerships, work as a team player and support execution of business objectives across teams, including timely escalations to TQ manager.
 * Primary Language required: English. Strong verbal and written communication skills.
 * Ability to work with dispersed/remote teams and support several projects simultaneously.
 * Experience with Acquisitions/Separations/ Divestiture efforts is desirable.