PpbResponsibilities /b /p /p liEstablishing new processes and equipment in the field of sterile manufacturing and its infrastructure /li liSpecifying new systems and components /li liSupporting operational readiness /li liEnsuring the technical availability of production and infrastructure facilities in accordance with applicable regulations (cGMP, safety), including spare parts management /li liEnsuring 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 /li liSupporting regulatory and customer inspections /li liCoordinating and supervising external and internal service providers /li liContinuously improving system availability, including updating and reviewing system documentation, as well as implementing corrective and proactive measures /li liProcessing change requests and deviation reports /li liPotential on-call duty /li pHardskills /p liBachelor’s or Master’s degree in engineering (mechanical engineering/process engineering, automation/systems engineering, chemistry, biology, pharmaceutical engineering, computer engineering), or equivalent technical training /li liExtensive experience in a GMP environment (ideally in sterile/aseptic production) /li liExperience in project management and the implementation of new equipment/processes /li liProficiency in working with systems such as Kneat and control systems /li liBusiness-level English proficiency; German skills are a plus /li pSoftskills /p liStrong problem-solving skills and ability to work independently /li liHigh standards of quality (with a focus on patient safety) /li liOpen communication and the ability to collaborate within a dynamic team /li liCompetent and professional demeanor when interacting with clients and government agencies /li liPrecise and meticulous work ethic /li pWe offer you /p liAn open and collaborative corporate culture /li liFreedom to contribute and develop ideas /li liOpportunities to participate in sports and social activities /li liProfessional development and continous learing opportunities, especially at our SKAN Academy /li liComprehensive and career-focused onboarding /li liQuick decision-making paths and flat hierarchies /li liTransparent and open communication /li li5 weeks of vacation, with the option to take additional leave /li pAdditional information /p pWe look forward to receiving your complete application documents (CV, diplomas and employment references) via our career page.br/For this position, we are focusing on direct applications and are not working with external agencies. Any dossiers submitted by agencies will not be processed. /p