Investigate deviations, discrepancies, and anomalies and support CAPA/re-testing. Lead CSV activities for large-scale, cross-functional SAP initiatives.
Numbers & Facts
Location
NULL, VA
Description
Job Description
Job Title: Senior Computer Systems Validation Expert Experience: 10+ Years Domain: 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
Strong stakeholder management and communication skills