Process Expert – Aseptics (m/f/d)
Core
Ensuring GMP-compliant aseptic behavior and leading qualification/validation activities in sterile pharmaceutical production environments.
Role type
Senior Process Expert (Aseptic Manufacturing)
Builds
Sterile drug products for global patient supply
Domain
Pharmaceutical manufacturing / Aseptic production
Required skills
Aseptic manufacturing principles, GMP compliance, Process validation, Media fill simulations, CAPA definition, GMP documentation management, Coaching and training
Preferred skills
Isolator filling technology experience, Drug-product manufacturing production experience
Technologies
Isolator systems, Media fill equipment
Responsibilities
Ensure and promote GMP-compliant aseptic behavior in production areas, Lead aseptic qualification and validation activities including process simulations, Actively present in production areas to train and support staff, Oversee process responsibility for relevant GMP procedures, Support deviation investigations and define CAPAs, Coordinate aseptic validation activities with production and quality teams
Seniority
Senior, hands-on IC