Pphe actual location of this job is in bStein, AG, Switzerland /b. Relocation assistance is available for eligible candidates and their families, if needed. /p h3What you’ll get: /h3 pAn agile career and dynamic working culture /p pAn inclusive and ethical workplace /p pCompensation programs that recognize high performance /p pAlong with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on assetstream.aspx /p h3Key responsibilities: /h3 pAct as the MSAT Expert in capital investment projects to build and commission manufacturing units, ensuring commercial readiness for the GMP manufacturing facility. /p pDefine qualification strategies and concepts for DP manufacturing equipment and clean rooms as part of the aseptic fillfinish lines in alignment with regulatory requirements (e.g EU GMP, FDA, ICH). Lead and act as a MSAT member in cross-functional project teams (e.g QA, Engineering, Manufacturing, QC). /p pProvide technical leadership during the design of the sterile manufacturing processes, including cleanroom layout, material/personnel flow, and equipment placement. /p pCraft the Aseptic Process Simulation concept in alignment with internal guidelines and regulatory requirements. Provide oversight and technical support during execution of APS and all investigations regarding the aseptic manufacturing process. Support the development of aseptic technique training programs. /p pLead risk assessments (e.g FMEA) to identify critical manufacturing process parameters and control strategies for the facility. Author and review GMP documents such as Qualification/Validation master plans, protocols and reports, SOPs, manufacturing concepts, etc. /p pEnsure GMP documentation readiness for authority inspections in line with internal and external quality standards. /p pContribute to the development and implementation of standardized MSAT procedures and processes, including qualification standards, single-use systems, and filtration systems. /p h3Key requirements: /h3 pUniversity Degree or equivalent technical education in Biotechnology, Pharmacy, or a related field /p pSignificant experience in aseptic/sterile fillfinish processes of drug products in a GMP environment is a must, with substantial know-how in aseptic processing and sterility assurance principles. /p pExperience in at least one of the following is a must: qualification of manufacturing equipment; cleaning validation; room qualification /p pStrong communication skills, able to translate complex technical topics into clear actionable messages. /p pProactive, positive approach, problem-solving attitude, and ability to take full responsibility for assigned areas. /p pAbility to lead cross-functional teams and drive decision-making in a matrix organization; build strong networks and trust across internal and external stakeholders. /p pProficiency in English is a must; German language skills are a plus. /p /p #J-18808-Ljbffr