Expert/in für Validierung und Qualifizierung im Sterilbereich (m/w/d)
Core
Planning and execution of validation, qualification, and calibration activities for the entire manufacturing area, including rooms and HVAC systems, plus planning and preparation of Aseptic Process Simulations (Media Fills).
Role type
Validation and Qualification Expert in Sterile Manufacturing
Builds
Sterile manufacturing processes and aseptic filling lines
Domain
Pharmaceutical manufacturing / Sterile processing
Required skills
Validation and qualification planning, Aseptic Process Simulation (Media Fills), HVAC system validation, regulatory inspection preparation, documentation management, project management, audit experience
Preferred skills
Experience in sterile filling, technical and organizational process understanding, data processing knowledge
Technologies
HVAC systems, data processing systems
Responsibilities
Plan and conduct validation, qualification, and calibration activities for manufacturing areas and HVAC; Plan and prepare Aseptic Process Simulations (Media Fills); Participate in regulatory and customer inspections; Create and maintain validation and qualification documentation
