Jobdetails Are you an experienced MES Specialist with a passion for optimizing production processes? We're looking for you to take charge of our MES system's life cycle, ensure its compliance, and actively shape the future of our manufacturing!
...General Information: Start date: asap
latest Start Date: 1.12.25
Planned duration: 12 months
Extension (in case of limitation): possible
Workload: 100%
Home Office: mostly onsite
Team: 12
Working hours: Standard
Tasks & Responsibilities: 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
Must Haves 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
We thank you for your application!mehr anzeigen Are you an experienced MES Specialist with a passion for optimizing production processes? We're looking for you to take charge of our MES system's life cycle, ensure its compliance, and actively shape the future of our manufacturing!
General Information: Start date: asap
latest Start Date: 1.12.25
Planned duration: 12 months
Extension (in case of limitation): possible
Workload: 100%
Home Office: mostly onsite
Team: 12
Working hours: Standard
Tasks & Responsibilities: 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
...Must Haves 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
We thank you for your application!mehr anzeigen