MES System Engineer (a), 80 - 100%

Bachem AG; Stein; In loco; CHF 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible hours with home office days

Additional vacation days via workload

Internal and external training

Pension fund contributions 60%

Partner discounts via platform

Descrizione del lavoro

Bachem Holding AG in Stein, Switzerland, seeks a dedicated MES System Engineer for its new site. You will lead the PAS-X MES lifecycle, shape future MES architectures, and drive activities from startup design through qualification to commercial manufacturing.

Requirements include a degree in a technical field and 4–6 years of PAS-X MES experience in regulated settings, plus strong IT/OT and regulatory knowledge. English fluency is essential; German is a plus.

Competenze

• Degree in a technical discipline relevant to automation or pharma engineering.
• 4–6 years hands-on PAS-X MES in regulated environments.
• Experience with MES deployments for new facilities or digital transforms.
• Strong IT/OT architectures and system integration knowledge.
• Knowledge of CSV/CSA, data integrity, and GMP requirements.

Mansioni

• Lead lifecycle management of Körber PAS-X MES: design, config, deployment, validation, and maintenance.
• Support next‑gen MES architectures aligned with Pharma 4.0 initiatives.
• Drive MES activities across startup lifecycle from design to go‑live and operations.
• Collaborate across manufacturing, automation, IT/OT, quality and digital teams.
• Translate manufacturing needs into robust MES designs; ensure availability and security.
• Manage change control, deviations, incidents, and problem resolution with IT/vendors.
• Integrate PAS-X with ERP, LIMS, Historians and automation platforms.
• Contribute to standardization, templates, and deployment methodologies.
• Maintain GMP-compliant documentation and audit readiness.
• Act as MES SME during audits and regulatory interactions.
• Support CSV/CSA activities per GAMP5 and data integrity requirements.

Conoscenze

PAS-X MES experience

GMP manufacturing

CSV/CSA knowledge

English fluent

German desirable

Formazione

Bachelor’s or Master’s degree in Automation/IT/CS/Pharma Eng

Strumenti

PAS-X modules (EBR, MMaterials, weigh & dispense, workflow)

ERP integration

LIMS

Historians

Descrizione del lavoro

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 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!

At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

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