Manufacturing System Engineer

Functieomschrijving

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 / 21

CFR 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.