Computerized Systems Validation Specialist
Core
Ensuring all IT systems impacting Good Manufacturing Practices (GMP) are in a validated state and managing the validation lifecycle for software and hardware changes.
Role type
Computerized Systems Validation (CSV) Specialist
Builds
Validated IT systems and documentation for pharmaceutical manufacturing environments
Domain
Pharmaceutical manufacturing / Quality Assurance / IT Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GAMP 5 knowledge, GMP regulations (Annex 11/Part 11), risk assessment, test protocol design, regulatory compliance, data integrity principles, cross-functional collaboration, audit support, documentation management
Preferred skills
Master or Bachelor in IT, HBO work level, pharmaceutical production environment experience, CSV study setup experience
Technologies
ERP, Electronic Batch Record (EBR), Asset management systems, Artwork management, Control systems, MS Office
Responsibilities
Maintain Computerized System Validation Master Plan and related procedures, create validation documents (risk assessments, test protocols, reports), coordinate validation studies with IT, Operations, and Engineering, conduct internal audits, support external audits as SME, assess validation needs for system/process changes, ensure compliance with international validation regulations
Seniority
Mid-level specialist
