MES System Engineer

• 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