Responsibilities:
1. Review, refine (also challenge status quo) existing manufacturing process requirements with manufacturing stakeholders; scope is the full E2E processes.
2. Simplify, harmonize and baseline manufacturing process requirements as far as possible.
3. Align manufacturing process requirements to technical requirements and towards out-of-the-box MES features & functions as far as possible in collaboration with Requirements Engineers and/or MES vendors.
4. Ensure GMP/GxP/CSV compliance.
5. Organize and lead requirements workshops, align business and IT needs & wants.
6. Collaborate with manufacturing process owners, enterprise and IT solution architects, requirements engineers, systems owners.
Qualifications:
1. Senior MES Expert with Business Analyst capabilities.
2. Several years of experience with MES systems and MES processes, preferably in the medical device or pharmaceutical industry.
3. Good understanding of top floor and shop floor processes, data models, IT/OT architectures and systems including integrations.
4. Proven experience in MES manufacturing processes and expertise in at least one MES product from Siemens, Tulip, and/or Rockwell.
5. Excellent understanding of how information flows along manufacturing processes.
6. Experience in business partnering, ability to quickly learn new business domains and processes.
7. GMP/GxP experience.
8. Strong stakeholder management, communication, and conflict management skills.
9. Analytical, structured, empathic, quality-conscious, target-oriented.
10. Fluent in English; fluent in German would be a big plus.
Work Environment:
1. You will work in an international environment.
2. A very renowned company.
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