INT-095161 07.10.2025

Manufacturing System Engineer

Zug
radio_button_unchecked
Pharmaceutical / Biotechnology / Chemical
radio_button_unchecked
Temporary full time

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)

Manufacturing System Engineer 100%

Description of the mission

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

Required profile

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.

Start date: asap - spätestens: 01.12.2025
Planned duration: 12 months
Extension (in case of limitation): possible
Home Office: mostly onsite

Are you interested and would you like to seize this opportunity? Then we should definitely get to know each other!  Simply click on "Apply now" and we look forward to receiving your complete application documents.