CSV Validavimo Inžinierius (-ė) | Kompiuterizuotos ir automatizuotos sistemos
Core
Engineer responsible for validating computerized and automated systems in manufacturing, laboratory, quality, and technical operations environments to ensure reliability and regulatory compliance.
Role type
Computerized System Validation (CSV) Engineer
Builds
Validated computerized and automated systems for production, laboratory, quality, and product supply processes
Domain
Life Sciences / Regulatory Manufacturing / Quality Assurance
Required skills
Computerized System Validation (CSV), GAMP5 principles, GMP compliance, Risk Assessment, Test Protocol Development, Change Control, Non-conformance Management, Technical Documentation, Data Integrity, Regulatory Principles
Preferred skills
LIMS, MES, ERP, QMS, SCADA, PLC, IQ/OQ/PQ, Statistical Process Control, Project Management, Quality Management Systems
Technologies
LIMS, MES, ERP, QMS, SCADA, PLC, MS Office
Responsibilities
Plan, coordinate, and execute CSV activities; Prepare, review, and execute validation documentation; Participate in system lifecycle activities; Identify and investigate validation deviations; Collaborate with cross-functional teams; Coordinate external vendor activities
Seniority
Mid-level, hands-on IC