MES System Engineer (a), 80 - 100%

Jobbasel; Bubendorf; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Home office days

Training opportunities

Pension fund contributions 60%

Discount platform access

Zusammenfassung

Bachem, a leading peptide-focused biotech company, seeks a MES System Engineer (80–100%) to drive full lifecycle management of the PAS-X MES at a new Northwestern Switzerland facility. You will align MES with Pharma 4.0, collaborate across functions, and ensure GMP-compliant operation through start‑up and commercial manufacturing phases.

The role emphasizes design, validation, and continuous improvement of MES platforms, with 24/7 operational readiness and cross-site standardization.

Qualifikationen

• Bachelor’s or Master’s degree in a related technical discipline.
• 4–6 years hands-on PAS-X MES in regulated pharma/biotech environments.
• Experience supporting MES implementations for new facilities or digital transformations.
• Solid understanding of next‑gen MES/IT-OT architectures and system integrations.
• Experience with PAS-X modules (EBR, MM, weigh & dispense, workflow design, MBR modeling).
• Administer a 24/7 MES with high availability, disaster recovery readiness.

Aufgaben

• Lead lifecycle management of Körber PAS-X MES from design to deployment and maintenance.
• Support next‑gen MES architectures aligned with Pharma 4.0.
• Drive MES activities across startup lifecycle from design to go‑live.
• Collaborate with manufacturing, automation, IT/OT, quality, and digital teams.
• Translate business processes into MES designs.
• Ensure GMP-compliant operation and on‑call support.

Kenntnisse

PAS-X MES

GMP compliance

CSV/CSA

IT/OT architecture

System integration

Regulatory audits

English Fluency

German language

Ausbildung

Bachelor's or Master’s in Automation Engineering

Tools

PAS-X modules

ERP integration

LIMS integration

Validation tooling

Jobbeschreibung

Bachem ist ein börsenkotiertes, auf die Peptid-Chemie fokussiertes Technologie-Unternehmen mit einem umfassenden Leistungsangebot für die Pharma- und Biotechnologie-Industrie. Bachem ist spezialisiert auf die Entwicklung innovativer, effizienter Herstellungsverfahren und die zuverlässige Produktion Peptid-basierter pharmazeutischer Wirkstoffe. Ein umfangreicher Katalog von Biochemikalien für Forschungszwecke und exklusive Kundensynthesen ergänzen das Angebot. Mit Hauptsitz in der Schweiz sowie Niederlassungen in Europa und den USA ist das Unternehmen weltweit tätig und verfügt über die industrieweit grösste Erfahrung und Fachkompetenz. In der Zusammenarbeit mit ihren Kunden legt Bachem grössten Wert auf Qualität, Innovation und Partnerschaft.

MES System Engineer (a), 80 - 100%

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 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

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