Senior Specialist - IT Quality and Computerized Systems Validation
Core
Provide hands-on support for Computerized System Validation (CSV) and IT Compliance activities for the Leiden Cell Therapy Facility, acting as a Subject Matter Expert for system changes, deviations, and audit readiness.
Role type
Senior Specialist, IT Quality and Computerized Systems Validation
Builds
Validated IT systems and automation projects for cell therapy manufacturing
Domain
Biotechnology / Cell Therapy Manufacturing / IT Quality & Compliance
Required skills
Computerized System Validation (CSV), GAMP5, GxP regulations, 21CFR Part 11, EudraLex Annex 11, SDLC, Change Control, Deviation Management, Root Cause Analysis, CAPA, Quality Systems (LIMS, QMS), Manufacturing Execution Systems (MES), ERP, Process Automation, Historians, Good Documentation Practices
Preferred skills
Cell Therapy experience, Supply Chain systems knowledge, Manufacturing domain knowledge
Technologies
Infinity (Change Management), LIMS, QMS, MES, ERP, Historians, Benchtop systems
Responsibilities
Provide technical input to operations on CSV matters, review and approve qualification documents, support regulatory audits as Digital Plant representative, execute CSV activities for deviations and change controls, update standard operating procedures (SOPs), assist in developing validation methodologies, interact with change management systems for investigations and CAPA.
Seniority
Senior, hands-on IC