MES System Engineer (a), 80 - 100%
Bachem Holding AG
Select how often (in days) to receive an alert: Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see . The 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 designphase of the project offers you unique opportunities to shape the future organization. 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 MES System Engineer (a) , 80 – 100%. Your Tasks Lead the full lifecycle management of the Körber PAS‑X Manufacturing Execution System (MES), including solution design, configuration, deployment, validation, maintenance, and continuous improvement Support the design and implementation of next‑generation MES architectures aligned with smart manufacturing, digital plant strategies, and Pharma4.0 initiatives Drive MES activities across the new facility startup lifecycle, from project design and commissioning through qualification, go‑live, and commercial manufacturing operations Collaborate with manufacturing, automation, IT/OT, quality, engineering, and global digital teams to define and implement scalable PAS‑X solutions Translate business and manufacturing process requirements into robust MES functional and technical designs Ensure high system availability, reliability, and performance for GMP‑regulated manufacturing environments, including on‑call and operational support where required Manage change control, deviation investigations, incident management, and problem resolution in close collaboration with IT, operations, and system vendors Support integration of PAS‑X with enterprise and shopfloor systems including ERP, LIMS, Historians, Automation and integration platforms Contribute to MES platform standardization, template strategies, and deployment methodologies across global manufacturing sites Maintain GMP‑compliant documentation throughout the system lifecycle, including specifications, risk assessments, validation deliverables, and operational procedures Act as MES Subject Matter Expert (SME) during audits, inspections, qualification activities, and regulatory interactions Support commissioning, qualification, and computerized system validation (CSV/CSA) activities in accordance with GAMP5 and data integrity requirements Your Profile Bachelor’s or Master’s degree in Automation Engineering, Information Technology, Computer Science, Pharmaceutical Engineering, or a related technical discipline 4 – 6 years of strong hands‑on experience with Körber PAS‑X MES in regulated pharmaceutical or biotech manufacturing environments Proven experience supporting MES implementation projects for new manufacturing facilities, site expansions, or large‑scale digital transformation programs Solid understanding of next‑generation MES/IT‑OT architectures, system integrations, and smart factory concepts Experience with PAS‑X modules such as electronic batch records (EBR), materials management, weigh & dispense, workflow design, and master batch record modelling is highly desirable Administer a 24/7 operational MES System, ensuring high availability, reliability, performance, and disaster recovery readiness. Knowledge of system integration technologies, infrastructure, networking, virtualization, and cybersecurity within GMP manufacturing environments Experience with computerized system validation (CSV/CSA), data integrity, and regulatory compliance requirements including GAMP5, Annex11, and 21CFR Part11 Strong understanding of pharmaceutical manufacturing processes, commissioning and qualification activities, and operational readiness for facility startup Excellent stakeholder management, communication, and cross‑functional collaboration skills Strong analytical and problem‑solving capabilities with the ability to operate effectively in fast‑paced project and operational environments Fluent in English; German language skills are highly desirable Our offer A dynamic and rapidly growing work environment with internal development opportunities Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction Employee development through numerous internal and external training opportunities 60% coverage of pension fund contributions by Bachem as well as option for extra‑mandatory pension provision with our Pension Plan Plus Access to benefits platform with discounts from external partners Would you like to drive innovation together with us? The (a) in the job title stands for all. Please note: unsolicited resumes from recruitment agencies will not be considered. #J-18808-Ljbffr
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