Computer System Validation (CSV) Engineer
Core
Plan, coordinate, and execute validation activities for new and existing GxP-regulated computerised systems across manufacturing, quality, and laboratory environments.
Role type
Mid-level Computer System Validation (CSV) Engineer
Builds
Validated computerised systems for pharmaceutical and life sciences manufacturing, quality, and lab operations
Domain
Pharmaceutical & Life Sciences / GxP Compliance
Required skills
Computer System Validation (CSV), GxP-Regulated Environments, Validation Planning & Execution, Requirements Verification & Testing, Risk Assessments & Traceability Matrices, Quality Assurance & Compliance, Documentation Review & Report Writing, Data Collection, Analysis & Interpretation, Change Control & Lifecycle Management, Stakeholder & Vendor Management, Audit & Inspection Support
Preferred skills
GAMP 5, EU GMP Annex 11, 21 CFR Part 11, ERP/MES/LIMS experience, Data Integrity principles (ALCOA+), Quality Management Systems (QMS), deviation management, CAPA processes
Technologies
ERP, MES, LIMS, Manufacturing Execution Systems, Laboratory Systems
Responsibilities
Plan, coordinate and execute validation activities for new and existing GxP-regulated computerised systems; Develop, review and maintain validation documentation including validation plans, protocols, test scripts, risk assessments, reports and traceability matrices; Perform system testing, verification and validation activities to ensure compliance with business, quality and regulatory requirements; Support audits, inspections and regulatory enquiries through the provision of validation documentation and evidence; Assess system changes and contribute to change control activities throughout the system lifecycle; Support data integrity initiatives and ensure systems remain compliant with applicable regulations and industry standards
Seniority
Mid-level (5-9 years of experience), hands-on IC