Expert (m/w/d) Lyo Filling
Core
Expert supporting the Lyo-Filling department in pharmaceutical production, focusing on aseptic filling, freeze-drying, and sterilization processes.
Role type
Senior IC pharmaceutical production expert (lyophilization/aseptic filling)
Builds
Lyo-filling lines and sterile products
Domain
Pharmaceutical manufacturing / Aseptic processing
Required skills
aseptic filling expertise, CAPA management, change control, GMP compliance, root cause analysis, training development, technical troubleshooting
Preferred skills
Master's degree in natural sciences or engineering, experience with product transfers and technical modifications, stakeholder collaboration
Technologies
lyophilization equipment, sterile filling systems, GMP documentation tools
Responsibilities
Create and manage deviations, CAPAs, and change controls; present site during internal/external audits and inspections; support product transfers and technical line modifications; implement new technologies; develop and conduct training for sterile areas; investigate complex issues in filling, freeze-drying, and sterilization; provide technical leadership for the department; collaborate cross-functionally with Regulatory Affairs, Engineering, and Qualification teams.