Manufacturing Systems Engineer (m/f/d)

workload: 100% - mostly onsite
location: Basel (CH)
work model: Contracting

Key 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 of our client in Basel
• Implementation, collaboration, and support in change management, qualification, and/or validation activities in accordance with our clients 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-Have Qualifications:

• Completed apprenticeship in IT or related field, or 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 language skills (spoken and written)