Job title - MES MBR Designer
Location – Guayama, Puerto Rico
1. Hands-On experience on MES systems such as Werum PAS-X/FTPC/Synceda etc. 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 and SKY batch record creation in MES systems such as Werum PAS-X/FTPC/Synceda etc.
5. Knowledge on Industry Standards S88 as ISA S95
1. Pharmaceutical validation concept
2. cGMP and GDP standards and GAMP Standards
1. Create business process flow diagram for pharmaceutical product recipes based on the paper batch record
2. Gather MES Site specific requirement analysis to develop URS and FRS
3. Logically breakdown the recipes/Mfg. process following S88 standards ( Procedure, Unit procedures, Operations phases) to configure the recipe in to MES systems such as Werum PAS-X/FTPC/Synceda etc.
4. Develop/create MBR design elements ( building blocks) and workflows in MES systems such as Werum PAS-X/FTPC/Synceda etc. for repetitive use in MBR creation to expedite the process
5. Gather master data and configure/ upload in MES systems such as Werum PAS-X/FTPC/Synceda etc. D/Q/P Environment.
6. Integrating MES systems such as Werum PAS-X/FTPC/Synceda etc. with SAP and other automation systems using standard interface. Configuration of system data – work centers, scales, barcode scanners, Printers
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
Thanks & Regards
Tanisha Systems Inc.
Job Types: Full-time, Contract
Salary: $60.00 to $80.00 /hour
initially they can provide remote due to virus when it over come you have to join the project onsite.
- Temporarily due to COVID-19