MES Design Engineer (a) 100%

MES Design Engineer (a) 100% # Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With a comprehensive range of services, Bachem offers products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide. Headquartered in Switzerland with locations in Europe, the USA, and Asia, Bachem operates internationally and possesses more than 50 years of experience and industry-unique expertise. The company is listed on the SIX Swiss Exchange. Further information at: www.bachem.com The Bachem Group is investing in a new planned location in the Sisslerfeld in Northwest Switzerland. This step is part of the long-term strategy to expand production capacities by the end of the decade. The new production site will play a central role in achieving these goals. The project's planning phase offers you unique opportunities to actively shape the organization of the future. To drive our continuous organic growth, we are always looking for highly qualified specialists. To strengthen our team in the Technical Operations area, we are looking for a committed personality as MES Design Engineer (a) 100% Your tasks: • Implementation, configuration, and validation of the MES system PAS-X for the new production line • Development and design of electronic Master Batch Records (eMBR) considering GMP standards and process requirements • Integration of the MES with the process control system (PCS 7 / PCS neo) to automate data flows and reduce manual entries • Implementation of an efficient Review-by-Exception concept for quality optimization and reduction of review effort • Close cooperation with the Production, Automation, Quality, and IT departments as well as global units to define and implement system requirements • Ensuring data integrity, GMP compliance, and traceability of manufacturing processes • Participation in qualification and validation activities (URS, FS, IQ, OQ) • Training and support of end users in using the MES • Ongoing further development of the system and support in Change Control processes Your profile: • Completed studies in the field of chemistry, life science, engineering, pharma technology, computer science, or a comparable qualification • Several years of experience with PAS-X in a GMP-regulated environment (Power User level) • Profound knowledge in the modeling of eMBRs and MES workflows • Experience in the integration of MES with PCS systems, especially Siemens PCS 7 (and ideally PCS neo) • Good knowledge of regulatory requirements (GMP, GAMP 5, data integrity, Annex 11 / CFR Part 11) • Analytical thinking skills, structured way of working, and affinity for digital solutions • Strong communication skills and ability to work in a team in an interdisciplinary environment • Optional: Experience in the administration of Windows and Windows Server systems, databases, and network knowledge • Knowledge in the area of IT System / Software Qualification (GMP, GAMP, CSV) • Basic knowledge in the area of automation (OPC UA) is an advantage • Strong team and communication skills as well as a structured, documentation-oriented way of working • Good German and English skills, both written and spoken Our offer: • A dynamic and strongly growing work environment with internal development and further training opportunities • Flexible working hours with the possibility for home office and the option to take additional vacation days with a reduced working percentage • In-house daycare center (KITA) on the Bachem Campus Bubendorf • 60% coverage of pension fund contributions by Bachem as well as the possibility for supra-mandatory provision with our choice savings plan • Access to benefit platforms with discounts at external partners • Fresh, healthy, and diverse food in our staff restaurant • Diverse free sports activities on the Bachem Campus Would you like to drive innovation together with us? Have we piqued your interest? Then we look forward to receiving your complete application documents via our application portal. Learn more about the Bachem Group and let yourself be inspired by our inspiring work environment at our location in Stein! At Bachem, you will find a diverse, multicultural team. (a) in the job title stands for everyone. We look forward to applications from all people. Skills and motivation count - completely independent of age or gender, origin, religion, or sexual orientation. *Note: Applications from recruitment agencies will not be considered.* Forward job advertisement via email