MES Engineer (m/f/d) – Biologics Manufacturing

nemensis ag; Schachen; Vor Ort; EUR 75.000 - 96.000; Teilzeit

Zusammenfassung

nemensis ag is seeking an MES Engineer (m/f/d) for Biologics Manufacturing. The role focuses on configuring and maintaining MES (PAS-X) recipes, supporting EBR execution, and driving changes within GMP batch records.

You will work in a state-of-the-art biotech setting, collaborating with senior engineers on validations, change controls, and site-wide MES integration with SAP systems.

Qualifikationen

• Bachelor's degree in Life Sciences or equivalent MES experience.
• 2–3 years in automation/engineering in Biologics/Pharma/Medical devices.
• Experience configuring and testing MES batch records.
• Knowledge of computer system validation / SDLC and change control (GAMP 5).
• Proficient English communication (B2/C1).

Aufgaben

• Take ownership of configuring, building, and maintaining MES (PAS-X) recipes and GMP batch records.
• Provide hands-on troubleshooting and day-to-day support for electronic batch record (EBR) execution in manufacturing operations.
• Contribute to investigations and deviations by identifying and resolving automation-and MES-related issues.
• Prepare, test, and document system changes to support the release of GMP batch records.
• Draft and progress Change Controls in a compliant and timely manner, working closely with senior engineers.
• Support integration activities between MES and the site's automation layer as well as SAP-based systems.
• Help develop and update SOPs and training materials, and deliver MES training sessions to end users.
• Support technology transfer activities from an MES perspective as new processes move into the production environment.

Kenntnisse

PAS-X experience

GAMP 5 knowledge

MES systems

Troubleshooting

English (B2/C1)

Ausbildung

Bachelor's degree in Life Sciences

Tools

PAS-X (MES tool)

Jobbeschreibung

MES Engineer (m/f/d) – Biologics Manufacturing

MES Engineer (m/f/d) – Biologics Manufacturing

Ready to bring precision and reliability to biopharmaceutical manufacturing? As an MES Engineer (m/f/d), you'll be at the heart of digital batch record execution in a state-of-the-art biotech facility.

• Location: Schachen, Canton of Lucerne
• Employment type: Temporary placement

About our client

Our client is a globally active biopharmaceutical manufacturer with a long-standing presence in Switzerland. Operating a state-of-the-art biotech production site in the Lucerne region, the company combines cutting-edge technology with a collaborative, multicultural work environment and has been repeatedly recognised as a Top Employer in Switzerland and across Europe.

Your responsibilities

• Take ownership of configuring, building, and maintaining MES (PAS-X) recipes and GMP batch records in line with defined design standards
• Provide hands-on troubleshooting and day-to-day support for electronic batch record (EBR) execution in manufacturing operations
• Contribute to investigations and deviations by identifying and resolving automation-and MES-related issues
• Prepare, test, and document system changes to support the release of GMP batch records
• Draft and progress Change Controls in a compliant and timely manner, working closely with senior engineers
• Support integration activities between MES and the site's automation layer as well as SAP-based systems
• Help develop and update SOPs and training materials, and deliver MES training sessions to end users
• Support technology transfer activities from an MES perspective as new processes move into the production environment

What you bring

• A Bachelor's degree in a Life Sciences discipline, or equivalent hands-on experience of at least 2-3 years in an MES environment; hands-on knowledge of PAS-X is a strong plus
• At least 2 years of experience in an automation or engineering role within Biologics, Pharma, Food, or Medical Device manufacturing
• Familiarity with computer system validation / SDLC principles and change control processes (e.g. GAMP 5)
• Practical exposure to configuring, testing, and executing MES batch records
• A solid, detail-oriented approach to problem-solving, with the ability to prioritise and know when to escalate
• Confident communication skills in English (B2/C1 level)
• Exposure to commissioning and validation activities or test protocol execution is a plus