Senior Specialist - IT Quality and Computerized Systems Validation
Core
Provide subject matter expertise and hands-on support for Computer System Validation (CSV) and IT Compliance activities for the Leiden Cell Therapy Facility.
Role type
Senior Specialist, IT Quality and Computerized Systems Validation
Builds
Validated computerized systems for cell therapy manufacturing and quality operations
Domain
Biotechnology / Cell Therapy Manufacturing / IT Compliance
Required skills
Computerized Systems Validation (CSV), GAMP5, GxP regulations, 21CFR Part 11, EudraLex Annex 11, SDLC, Change Control, Deviation Management, CAPA, Root Cause Analysis, MES, LIMS, QMS, ERP, Process Automation, Historians, Good Documentation Practices
Preferred skills
Cell Therapy experience, IT Quality & Compliance applications in bio-tech manufacturing
Technologies
Infinity (Change Management system), MES, LIMS, QMS, ERP, Historians, Benchtop systems
Responsibilities
Provide hands-on support for CSV activities, projects, deviations, and change controls; Act as CSV Subject Matter Expert (SME) for IT/Automation projects; Review and approve qualification documents; Support regulatory audits as a Digital Plant representative; Execute CSV activities and support investigations; Update Digital Plant standard operating procedures (SOPs); Assist in development of validation methodologies
Seniority
Senior Specialist, hands-on IC