MES System Engineer (a), 80 - 100%

pThe Bachem Group is investing in a new planned site in Sisslerfeld in Northwestern Switzerland. This step is part of the long-term strategy to expand production capacity by the end of the decade. The new production site will play a central role in achieving these goals. The design phase of the project offers you unique opportunities to shape the future organization.br/To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our team in Global IT, we are looking for a dedicated bMES System Engineer /b(a), 80 - 100%.br/ /ph3Your Tasks: /h3ulliLead the full lifecycle management of the Körber PAS-X Manufacturing Execution System (MES), including solution design, configuration, deployment, validation, maintenance, and continuous improvement /liliSupport the design and implementation of next-generation MES architectures aligned with smart manufacturing, digital plant strategies, and Pharma 4.0 initiatives /liliDrive MES activities across the new facility startup lifecycle, from project design and commissioning through qualification, go-live, and commercial manufacturing operations /liliCollaborate with manufacturing, automation, IT/OT, quality, engineering, and global digital teams to define and implement scalable PAS-X solutions /liliTranslate business and manufacturing process requirements into robust MES functional and technical designs /liliEnsure high system availability, reliability, and performance for GMP-regulated manufacturing environments, including on-call and operational support where required /liliManage change control, deviation investigations, incident management, and problem resolution in close collaboration with IT, operations, and system vendors /liliSupport integration of PAS-X with enterprise and shopfloor systems including ERP, LIMS, Historians, Automation and integration platforms /liliContribute to MES platform standardization, template strategies, and deployment methodologies across global manufacturing sites /liliMaintain GMP-compliant documentation throughout the system lifecycle, including specifications, risk assessments, validation deliverables, and operational procedures /liliAct as MES Subject Matter Expert (SME) during audits, inspections, qualification activities, and regulatory interactions /liliSupport commissioning, qualification, and computerized system validation (CSV/CSA) activities in accordance with GAMP5 and data integrity requirements /li /ulh3Your Profile: /h3ulliBachelor’s or Master’s degree in Automation Engineering, Information Technology, Computer Science, Pharmaceutical Engineering, or a related technical discipline /lili4 – 6 years of strong hands‑on experience with Körber PAS‑X MES in regulated pharmaceutical or biotech manufacturing environments /liliProven experience supporting MES implementation projects for new manufacturing facilities, site expansions, or large-scale digital transformation programs /liliSolid understanding of next‑generation MES/IT‑OT architectures, system integrations, and smart factory concepts /liliExperience with PAS‑X modules such as electronic batch records (EBR), materials management, weigh dispense, workflow design, and master batch record modeling is highly desirable /liliAdminister a 24/7 operational MES System, ensuring high availability, reliability, performance, and disaster recovery readiness. /liliKnowledge of system integration technologies, infrastructure, networking, virtualization, and cybersecurity within GMP manufacturing environments /liliExperience with computerized system validation (CSV/CSA), data integrity, and regulatory compliance requirements including GAMP5, Annex 11, and 21 CFR Part 11 /liliStrong understanding of pharmaceutical manufacturing processes, commissioning and qualification activities, and operational readiness for facility startup /liliExcellent stakeholder management, communication, and cross‑functional collaboration skills /liliStrong analytical and problem‑solving capabilities with the ability to operate effectively in fast‑paced project and operational environments /liliFluent in English; German language skills are highly desirable /li /ulh3Our offer /h3ulliA dynamic and rapidly growing work environment with internal development opportunities /liliFlexible working hours with home office days and an option for obtaining additional vacation days through workload reduction /liliEmployee development through numerous internal and external training opportunities /lili60% coverage of pension fund contributions by Bachem as well as option for extra‑mandatory pension provision with our Pension Plan Plus /liliAccess to benefits platform with discounts from external partners /li /ulWould you like to drive innovation together with us?br/Learn more about the Bachem Group and get inspired by our exciting work environment at our new location in Stein!