Job Description
Responsibilities
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 Processing cha...