Senior Computer Systems Validation (Csv) Expert
Tech3pillars Technologiesarlington, VA
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Overview
Remote
On-site
Job Description
Job Description
Job Title: Senior Computer Systems Validation ExpertExperience: 10+ YearsDomain: Life Sciences / Pharmaceutical / GxP
Must-Have Skills
- 10+ Years of CSV Experience
- 10+ Years of SAP System Validation
- GxP / GMP Regulated Environment
- CSV / SDLC Practices
- SAP S/4HANA / BTP / MDG
- Risk-Based Validation
- Change Control & Impact Assessment
- URS / Functional Requirements
- Validation Protocols & Test Execution
- Requirements Traceability Matrix (RTM)
- Data Migration Validation
- Validation Summary Reports
- Risk Assessments / DRA
- Deviation / Discrepancy Management
- Root Cause Analysis & CAPA
- Inspection-Ready Documentation
Required Experience
- Lead CSV activities for large-scale, cross-functional SAP initiatives.
- Develop and implement risk-based validation strategies.
- Lead validation risk assessments for system functionality and data flows.
- Ensure complete traceability from requirements through testing.
- Coordinate validation activities across Business, Digital, QA, QC, Infrastructure, and vendors.
- Review test execution and ensure objective validation evidence is properly documented.
- Investigate deviations, discrepancies, and anomalies and support CAPA/re-testing.
- Prepare and review key CSV deliverables and ensure compliance with GxP requirements.
Preferred
- Experience validating AI solutions in a GMP environment
- CSV leadership for Manufacturing and Supply Chain digital projects
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