Werum PAS-X MES MBR Designer

Job Description

Primary Skill and Competencies

1. Werum PAS-X product hands-on experience for Full application configurations including interface with SAP and automation systems
2. In-depth of knowledge of Pharmaceutical business process (Chemicals (W&D, Solid bulk Mfg., packaging and other unit operations), Bio Pharma processes)
3. Creation of business process flow diagram
4. Master Batch Record creation in Werum PAS-X
5. Knowledge on Industry Standards S88 and ISA S95

c. Job Responsibility :

1. Create business process flow diagram for pharmaceutical product recipes based on the paper batch record or source documents
2. Gather MES Site specific requirement analysis to develop URS and FRS
3. Logically breakdown the recipes/Mfg. process to configure the recipe in to Werum PAS-X
4. Develop/create MBR design elements (building blocks) and workflows in Werum PAS-X for repetitive use in MBR creation to expedite the process
5. Gather master data and configure in Werum PAS-X Development/Quality/Production Environment.
6. Integrating Werum PAS- X with SAP and other automation systems using standard interface component of MBR design.
7. Lead the recipe design session with business process SMEs
8. Design MBR/recipe, equipment workflow/ status diagram based on the Business process flow
9. Create solution design and configuration document
10. Assist Validation engineer in authoring and execution of OQ/SITs including Interface testing
11. Support Unit testing in D environment and business verification testing in Q environment
12. Prepare key user training documents and impart key user training
13. Provide assistance in business SOP creation
14. Support FAT/UAT execution
15. Perform go-live/ cut-over activities
16. Provide hypercare/early life adoption support