MES System Engineer

Bachem

Stein, Switzerland

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 Pharma 4.0 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 modeling 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, Annex 11, and 21 CFR Part 11
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