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# CSV Lead

- **Company:** Katalyst Talent Agency
- **Location:** Piscataway, NJ, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Data Integrity, Laboratory Information Management Systems, SAP (Applications), System Testing, Iq/oq/pq, Enterprise Software Applications, Test Scripts, Computerised Systems, Trackwise, Veeva, GXP
- **Published:** November 9, 2026
- **Apply:** https://www.thejobnetwork.com/job/6d9ed767-fd60-42ef-b51b-b10ef608d6b1/csv-lead

## About the Role

* 10 years of experience in CSV / Computer System Validation within Pharma, Biotech, Medical Device, or Life Sciences.
 * Strong knowledge of GxP validation lifecycle and risk-based validation approaches.
 * Hands-on experience with URS, FS/DS, IQ/OQ/PQ, UAT, RTM, and validation reports.
 * Strong knowledge of 21 CFR Part 11, GAMP5, FDA, and data integrity requirements.
 * Experience with deviations, CAPA, change control, and risk assessments.
 * Strong technical documentation and project leadership skills.
 * Experience working with cross-functional teams in regulated environments
 * Experience with laboratory systems such as LIMS, CDS, ELN, or SDMS.
 * Experience with manufacturing systems, MES, ERP, or automation-related systems.
 * Experience with systems such as LabWare, Empower, TrackWise, Veeva, or SAP.
 * Experience with data integrity assessments and audit/inspection support.
 * Experience leading CSV teams and managing multiple validation projects.

## Description

* Lead and manage Computer System Validation (CSV) activities across regulated Life Sciences projects.
 * Develop and review validation plans, protocols, test scripts, reports, and validation documentation.
 * Lead validation lifecycle activities including URS, FS/DS, IQ, OQ, PQ, UAT, and RTM.
 * Perform risk assessments and ensure systems are validated in compliance with GxP requirements.
 * Support validation of GxP computerized systems, laboratory systems, manufacturing systems, and enterprise applications.
 * Manage deviations, CAPA, change controls, and validation-related investigations.
 * Provide technical leadership and coordinate with QA, IT, Engineering, Manufacturing, and Business teams.
 * Ensure compliance with FDA regulations, 21 CFR Part 11, GAMP5, and data integrity requirements.
 * Support audits, inspections, and inspection-readiness activities.
 * Manage project timelines, deliverables, and validation documentation.