> Markdown version of [/jobs/ext/4545427-senior-csv-analyst](https://www.wearedevelopers.com/jobs/ext/4545427-senior-csv-analyst). 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).

---

# Senior CSV Analyst

- **Company:** Katalyst Talent Agency
- **Location:** San Francisco, CA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Microsoft Access, Software Applications, Electronic Signatures, Laboratory Information Management Systems, SAP (Applications), Software Requirements Analysis, System Testing, Strategies of Testing, Iq/oq/pq, Test Scripts, Computerised Systems, Information Technology, Veeva, GXP
- **Published:** November 3, 2026
- **Apply:** https://www.thejobnetwork.com/job/9e2af8d7-b8db-4c14-ae18-51aab71f334b/senior-csv-analyst

## About the Role

We are seeking an experienced Senior Computer System Validation (CSV) Analyst to support validation and compliance activities for GxP computerized systems in a regulated pharmaceutical/biotechnology environment. The ideal candidate will have strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, risk-based validation, and Computer Software Assurance (CSA) principles., * Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, Pharmacy, or a related field.

 * 5 8 years of experience in Computer System Validation, Quality Systems, or GxP IT environments.
 * Strong experience validating GxP computerized systems in pharmaceutical, biotechnology, medical device, or other regulated industries.
 * Hands-on experience with GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA.
 * Experience with enterprise GxP applications such as Veeva, SAP, LIMS, MES, QMS, ERP, or clinical systems is preferred.
 * Strong technical writing, analytical, problem-solving, and communication skills.
 * Ability to manage multiple validation projects and priorities in a regulated environment.

## Description

* Lead and execute Computer System Validation (CSV) activities throughout the system lifecycle.
 * Develop and maintain Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, test protocols, and validation reports.
 * Execute and document IQ/OQ/PQ, UAT, regression, and risk-based testing as applicable.
 * Ensure computerized systems remain in a validated state throughout their lifecycle.
 * Perform GxP impact assessments, validation risk assessments, and system categorization.
 * Apply GAMP 5 and CSA principles to validation strategies and testing approaches.
 * Support 21 CFR Part 11 and EU Annex 11 compliance assessments.
 * Review system requirements, specifications, test scripts, and traceability matrices.
 * Support Change Control, Deviation, CAPA, and Periodic Review activities.
 * Review and assess audit trails, user access, electronic records, and electronic signatures.
 * Support internal audits and FDA/regulatory inspection readiness.
 * Collaborate with IT, Quality Assurance, Business Process Owners, System Owners, and vendors.
 * Identify validation gaps and develop appropriate remediation strategies.
 * Ensure validation documentation is accurate, complete, traceable, and inspection-ready.
 * Support system upgrades, implementations, migrations, and integrations.
 * Provide technical guidance and mentoring to junior CSV team members.