CQV Ingenieur / Qualifizierungs- und Validierungsspezialist 80-100% (m/w/d)
Core
Responsible for qualification and validation of process engineering equipment and facilities, ensuring process optimization and technical knowledge for plant personnel.
Role type
Senior IC process engineering qualification and validation specialist
Builds
Process engineering equipment and facilities for pharmaceutical manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process engineering equipment qualification, facility validation, deviation management, change control (GEP/GMP), CAPA coordination, audit presentation, project coordination
Preferred skills
COMOS (Plant Engineering Software), DMS, TrackWise, SAP
Technologies
COMOS, DMS, TrackWise, SAP
Responsibilities
Create commissioning and qualification documents for new plants, support retrofit/expansion/new build projects, manage deviations and changes, coordinate internal groups and external vendors, present qualification documents during audits
Seniority
Senior, hands-on IC
