Job Summary
Job Title:MES MBR Designer
Job location:Guayama, Puerto Rico
Job Type:Contract/ Full-time
Primary Skill-
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
In-depth of knowledge of Pharmaceutical business process ( Chemicals ( W&D, Solid bulk Mfg., packaging and other unit operations), Bio Pharma processes)
Creation of business process flow diagram
Master Batch Record creation and SKY batch record creation in MES systems such as Werum PAS-X/FTPC/Synceda etc.
Knowledge on Industry Standards S88 as ISA S95
Secondary Skill:
Pharmaceutical validation concept
cGMP and GDP standards and GAMP Standards
Responsibility:
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 S88 standards ( Procedure, Unit procedures, Operations phases) to configure the recipe in to MES systems such as Werum PAS-X/FTPC/Synceda etc.
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
Gather master data and configure/ upload in MES systems such as Werum PAS-X/FTPC/Synceda etc. D/Q/P Environment.
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
Lead the recipe design session with business process SMEs
Design MBR/recipe, equipment workflow/ status diagram based on the Business process flow
Create solution design and configuration document
Assist Validation engineer in authoring and execution of OQ/SITs including Interface testing
Support Unit testing in D environment and business verification testing in Q environment
Prepare key user training documents and impart key user training
Provide assistance in business SOP creation
Support FAT/UAT execution
Perform go-live/ cut-over activities
Provide hypercare/early life adoption support
Thanks & Regards,
Pawan Singh
Tanisha Systems Inc.
Tel: 212 729 6543 x 416
Email: pawan()tanishasystems.com
Job Types: Full-time, Contract
Experience:
MES: 1 year (Required)
master batch records: 1 year (Preferred)
MBR: 1 year (Preferred)
MBR designer: 1 year (Preferred)
manufacturing execution systems: 1 year (Preferred)
Full Time Opportunity:
Yes
