Validavimo inžinierius (-ė) | Įrangos ir sistemų kvalifikavimas – Vilnius
Core
Plan, execute, and control equipment and system qualification activities per ISO 13485 and IVDR requirements; oversee third-party vendor work.
Role type
Equipment and System Qualification Engineer
Builds
Qualified equipment and systems for life sciences and diagnostics manufacturing and laboratory processes
Domain
Life Sciences / Diagnostics / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification planning and execution, Third-party vendor oversight, Data entry into quality systems, Audit participation, Technical documentation reading (drawings, diagrams, instructions), Quality management system standards knowledge
Preferred skills
Aseptic manufacturing principles, Controlled environment work experience
Technologies
MS Office
Responsibilities
Plan, perform, and control equipment and system qualification activities per ISO 13485 and IVDR requirements; Oversee third-party vendor equipment and system qualification work; Ensure accurate data entry into accounting and quality systems; Participate in external and internal audits; Report non-standard situations to direct supervisor; Maintain confidentiality of work-related information