Establishing new processes and equipment in the field of sterile manufacturing and its infrastructure
Specifying new systems and components
Supporting operational readiness
Ensuring the technical availability of production and infrastructure facilities in accordance with applicable regulations (cGMP, safety), including spare parts management
Ensuring and overseeing the performance of calibrations, maintenance, and support for the qualification of production and infrastructure facilities, such as isolator filling systems, autoclaves, ventilation systems, and ultrapure water systems
Supporting regulatory and customer inspections
Coordinating and supervising external and internal service providers
Continuously improving system availability, including updating and reviewing system documentation, as well as implementing corrective and proactive measures