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Mes Specialist

vor 2 Wochen

Munich, Deutschland Axiom Software Solutions Vollzeit

**Job Description**:
Job Title - MES Specialist

Location - Unterschleisscheim, Germany (Hybrid)

Work type - Hybrid

Project Duration - 6-12 Months

Job Description
- **Preferred Skills**:
Bachelor’s Degree or Higher

5+ years of professional experience in the MES product knowledge, Pharmaceutical validation concepts and documentation, Pharmaceutical business process domain knowledge cGMP and GDP standards and GAMP Standards

MES product knowledge, Pharmaceutical validation concepts and documentation, Pharmaceutical business process domain knowledge cGMP and GDP standards and GAMP Standards

Good understanding in communication of MES and SAP/other interfacing automation components. Application knowledge in JBoss server functionality and MES Print functionalities.

MBR Designing, MES to SAP, MES to Automation interface knowledge

Create business process flow diagram for pharmaceutical product recipes based on the paper batch record. Gather MES Site specific requirement analysis to develop URS and FRS.

Logically breakdown the recipes. Mfg. process following standards Procedure Unit procedures Operations phases to configure the recipe in to Werum MES (PAS-X).

Good written and verbal communication skills to effectively communicate with technical and business users.

Knowledge in GxP terms as per 21 CFR PART 11, Compliance issues and Documentation. Nice to have a Pharmaceutical domain expertise.

Experience identifying operational issues and recommending and implementing strategies to resolve problems

Proficiency in German language

**Job Roles/Responsibilities**:
Develop create MBR design elements building blocks and workflows in Werum MES (PAS-X) for repetitive use in MBR creation to expedite the process.

Gather master data and configure upload in Werum MES (PAS-X) Environment & Integrating Werum PAS X with SAP and other automated systems using standard interface.

Execution of change requests for support and any enhancements as required.

Update MES documents such as DS, SOP, IQ Protocols as needed for tickets resolutions or any enhancements as required.

Configuration of system data work centers scales, barcode scanners and printers.

Lead the recipe design session with business process SMEs & Design MBR recipe equipment workflow status diagram based on the Business process flow.

Coordinate and support with respective groups/departments and vendors for implementation or hyper care activities after patch or system upgrades.

**Skills**:
Domain Expertise, Verbal Communication Skill, Verbal Communication Skills, Compliance, Jboss, Workflow, Communication Skill, Written And Verbal Communication, Documentation, Product Knowledge

About Company