MES System Engineer (a), 80 - 100%

Bachem Holding AG; Indiana (PA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Flexible working hours

Employee development opportunities

Access to benefits platform

Job summary

Bachem Holding AG is seeking a dedicated MES System Engineer (80 – 100%) to lead the management of Körber PAS-X Manufacturing Execution System. This role involves supporting MES architectures aligned with smart manufacturing and ensuring compliance in GMP-regulated environments.

The ideal candidate will have a relevant degree and 4-6 years of experience in the pharmaceutical or biotech sector, with strong communication skills and the ability to work cross-functionally. Flexible working hours and development opportunities are offered.

Qualifications

• 4-6 years of experience in regulated pharmaceutical or biotech manufacturing environments.
• Experience with computerized system validation (CSV/CSA) and regulatory compliance.
• Solid understanding of next-generation MES/IT-OT architectures and smart factory concepts.

Responsibilities

• Lead the lifecycle management of Körber PAS-X MES.
• Support the design of next-generation MES architectures aligned with smart manufacturing.
• Drive MES activities across the new facility startup lifecycle.

Skills

Hands-on experience with Körber PAS-X MES

Strong analytical and problem-solving capabilities

Stakeholder management

Education

Bachelor’s or Master’s degree in Automation Engineering or related field

Tools

Körber PAS-X MES

GMP manufacturing systems

System integration technologies

Job description

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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 www.bachem.com .

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 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, 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?

The (a) in the job title stands for all.

Please note: unsolicited resumes from recruitment agencies will not be considered.