Responsibilities
* Establishment of new processes and equipment in the area of sterile production manufacturing and its infrastructure
* Responsible for the technical availability of production and infrastructure facilities in accordance with applicable regulations (cGMP, safety), including spare parts management
* Ensuring and taking responsibility for the maintenance and requalification of production and infrastructure facilities, such as isolator filling systems, autoclaves, ventilation and ultrapure water systems
* Support during inspections by authorities
* Monitoring of external and internal service providers
* Continuous improvement of plant availability, including updating and reviewing plant documentation, including implementation of corrective and predictive measures
* Processing of change requests and deviation reports
Hardskills
* University or technical college degree in Engineering (mechanical engineering / process engineering, automation / systems engineering, chemistry, biology, pharmaceutical engineering, technical computer science)
* Many years of experience in the GMP environment (ideally in sterile / aseptic production)
* Relevant experience in project management and implementation of new equipment / processes
* Good knowledge of systems such as Kneat and control systems
* Business fluent German and English
Softskills
* High problem-solving skills and independence
* High quality standardsOpen communication and ability to work in a dynamic team
* Competent and professional manner when dealing with customers and authorities
* Precise and careful working style
We offer you
* An open and collegial corporate culture
* Room for ideas
* Support through further training, especially at our SKAN Academy
* Intensive and job-orientated induction training
* Short decision-making processes and flat hierarchies
* Open communication policy
* 5 weeks holiday and the possibility of additional days off / 40h work week
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