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 preparation of Aseptic Process Simulations (Media Fills).
Role type
Validation and Qualification Specialist (Sterile Manufacturing)
Builds
Sterile pharmaceutical manufacturing processes and compliant facilities
Domain
Pharmaceutical industry + Sterile manufacturing
Required skills
Validation planning, Qualification execution, Calibration management, Aseptic Process Simulation (Media Fills), Regulatory inspection support, Technical documentation, Project management, Audit participation
Preferred skills
Project work experience, Audit experience
Technologies
HVAC systems, Data processing systems (via careerplan.io/jobs/2621529-expertin-fur-validierung-und-qualifizierung-im-sterilbereich-mwd)
Responsibilities
Plan and conduct validation, qualification, and calibration activities for manufacturing areas and HVAC systems; Plan and prepare Aseptic Process Simulations (Media Fills); Participate in regulatory and customer inspections; Create and maintain validation and qualification documentation.