Main Responsibilities:
1. Manage the life cycle of the Manufacturing Execution System (MES).
2. Adjust master data within automation systems according to standard operating procedures.
3. Implement, collaborate, and support change management, qualification, and validation activities following internal guidelines.
4. Perform root cause analysis, validate resolution proposals, and ensure compliance with ITSM processes.
5. Create and revise SOPs and automation/MES-related documentation.
6. Train new employees on MES usage and ensure adherence to GMP, GDP, and other regulatory requirements.
7. Collaborate closely with MES teams, first-level support, business representatives, and stakeholders.
8. Contribute to continuous improvement initiatives to streamline and consolidate processes.
Qualifications and Experience:
9. Completed apprenticeship in IT, automation, or related field (or equivalent qualification).
10. Strong background in manufacturing systems administration and support, with solid GxP knowledge.
11. In-depth understanding of business processes related to manufacturing systems.
12. Experience with IT Service Management (ITSM) processes and tools (e.g. ServiceNow) and deviation/change management tools (e.g. Veeva).
13. Proven CSV knowledge; familiar with Annex 11/21 CFR Part 11, GAMP 5, and data integrity guidelines.
14. Working knowledge of continuous improvement principles.
15. Fluent in German and good English, both spoken and written (must-have).