Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor‑made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories. Overview To support the development of our newly established subsidiary “maeven AG,” we are seeking an experienced professional with expertise in equipment qualification and CSV within the GxP pharmaceutical environment. In this role, you will be responsible, among other things, for implementing and executing the qualification strategy for our process equipment. Your responsibilities will also include overseeing and coordinating FATs as well as preparing the necessary qualification documentation. You can expect to join a dynamic and dedicated team. In this role, you will make a decisive contribution to the successful completion of our projects. Responsibilities Establish new processes and equipment in the field of sterile manufacturing and its infrastructure Specify new systems and components Support operational readiness Ensure the technical availability of production and infrastructure facilities in accordance with applicable regulations (cGMP, safety), including spare parts management Ensure and oversee 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 Support regulatory and customer inspections Coordinate and supervise external and internal service providers Continuously improve system availability, including updating and reviewing system documentation, as well as implementing corrective and proactive measures Process change requests and deviation reports Potential on‑call duty Hard skills Bachelor’s or Master’s degree in engineering (mechanical engineering/process engineering, automation/systems engineering, chemistry, biology, pharmaceutical engineering, computer engineering), or equivalent technical training Extensive experience in a GMP environment (ideally in sterile/aseptic production) Experience in project management and the implementation of new equipment/processes Proficiency in working with systems such as Kneat and control systems Business‑level English proficiency; German skills are a plus Soft skills Strong problem‑solving skills and ability to work independently High standards of quality (with a focus on patient safety) Open communication and the ability to collaborate within a dynamic team Competent and professional demeanor when interacting with clients and government agencies Precise and meticulous work ethic We offer you An open and collaborative corporate culture Freedom to contribute and develop ideas Opportunities to participate in sports and social activities Professional development and continous learing opportunities, especially at our SKAN Academy Comprehensive and career‑focused onboarding Quick decision‑making paths and flat hierarchies Transparent and open communication 5 weeks of vacation, with the option to take additional leave Contact For questions please contact Viviane Braxton. #J-18808-Ljbffr
Experienced Plant Engineer
