MES System Engineer (a), 80 - 100%

Bachem; Stein; On-site; CHF 110,000 - 160,000; Full time

Benefits offered by this job

Flexible working hours

Home office days

Pension plan 60% coverage

Training opportunities

Employee discounts

Job summary

Bachem Group is expanding with a new site in Sisslerfeld, Northwestern Switzerland, and seeks a dedicated MES System Engineer to lead the PAS-X MES across the facility startup and ongoing GMP operations.

The role requires 4–6 years of hands-on PAS-X MES experience in regulated pharma or biotech manufacturing, with strong IT/OT integration and regulatory compliance knowledge.

Qualifications

• Bachelor’s or Master’s degree in a technical field such as Automation, IT, CS or Pharmaceutical Engineering.

Responsibilities

• Lead the full lifecycle management of Körber PAS-X MES across the plant startup and operations.
• Design, configure, deploy, validate and maintain MES solutions aligned with Pharma 4.0.
• Ensure high availability and compliance in GMP environments.
• Collaborate with IT/OT, manufacturing, QA and global digital teams.
• Support CSV/CSA, deviations, change control and audits.

Skills

Analytical skills

Cross-functional collaboration

Stakeholder management

Communication

Project management

Education

Bachelor’s or Master’s degree in Automation Engineering, IT, CS, Pharmaceutical Engineering

Tools

PAS-X MES

PAS-X EBR

Materials management

Weigh & dispense

Workflow design

Master batch record modeling

Job description

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 design phase 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

Would you like to drive innovation together with us?
Learn more about the Bachem Group and get inspired by our exciting work environment at our new location in Stein!