Computerized System Validation Specialist
Core
Ensuring reliable and compliant computerized systems for life-saving nutritional and pharmaceutical products through Computerized System Validation (CSV), Data Integrity, and GMP compliance.
Role type
Senior CSV Specialist / SME
Builds
Compliant computerized systems for production, laboratories, facilities, and utilities
Domain
Pharmaceutical manufacturing / GMP compliance
Deliverable
client delivery
Required skills
CSV project leadership, validation documentation coordination, deviation/CAPA handling, audit/inspection support, lifecycle management, regulatory translation (NIS2, Annex 11, CSA), SME advisory
Preferred skills
Process Engineering or Automation background, stakeholder management
Technologies
GAMP5, NIS2, GMP Annex 11, CSA
Responsibilities
Lead complex validation and implementation projects; develop CSV standards, governance and procedures; translate new regulations into the organization; coach colleagues and advise management; prepare, review and coordinate validation documentation; handle deviations, exceptions and CAPAs; support audits and inspections; ensure compliant lifecycle management of computerized systems
Seniority
Senior, hands-on IC with SME responsibilities