Manufacturing System Engineer

• Responsible for Life Cycle Management of the MES System
• Master data adjustments in the automation systems in accordance with the standard operating procedures applicable within the MES system in Basel
• Implementation, collaboration, and support in change management, qualification, and/or validation activities in accordance with Roche's internal guidelines
• Perform root cause analysis, validate resolution proposals, and ensure compliance and monitoring of business errors in alignment with ITSM principles.
• Creation and revision of documents in the area of responsibility (SOPs), such as the creation of automation and MES-related regulations and SOPs
• Training of new employees to introduce them to MES
• Ensure adherence to regulatory requirements such as Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and other relevant regulations
• Promoting collaboration with other MES teams such as First level Support, Business representatives and other stakeholders
• Continuous improvement process activities to streamline and consolidate processes

• Completed apprenticeship in IT or a related field, or an equivalent qualification
• In-depth understanding of business processes related to manufacturing systems.
• Strong background in systems administration and support for manufacturing systems including strong knowledge with GxP.
• Experience with IT Service Management (ITSM) processes and proficiency in using support tools (e.g. SNOW) for request and change management and business deviation management tools (e.g. Veeva).
• Proven CSV Knowledge / Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
• Working knowledge of continuous improvement principles.
• Fluency in German and good English, both spoken and written, is essential.

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting. For our client F. Hoffmann - La Roche in Kaiseraugst, we are looking for a motivated and reliable (m/f/d)