MES Engineer

MBR-MES Engineer

Roles/Responsibilities

· Lead Business Process Re-engineering for pharmaceutical product recipes based on the paper batch record or source documents.

• Lead MES Requirements management for development of URS and FRS.

• Lead Recipe development for biotech/ pharma manufacturing processes.

• Lead MBR design elements (building blocks) and e-logbook workflows for repetitive use in MBR creation to expedite the process.

• Gather master data and configure in MES Development/Quality/Production Environment.

• Lead MES integration with external systems.

• 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.

• Prepare key user training documents and impart key user training.

• Provide assistance in business SOP creation.

Required Qualifications

• A bachelor's degree in computer science, Computer Engineering, Computer Information Systems, or a related field (Technology Management; Chemical Engineering)

• Intermediate level MES experience desired on any of MES platforms preferably FTPS

• Total 6+ years of hands-on experience on MES Product in MBR designing role.

• MES product hands-on experience for Full application configurations including interface with SAP and automation systems.

• In-depth of knowledge of Bio Pharma processes

• Creation of business process flow diagram

• Master Batch Record creation in MES

• Knowledge on Industry Standards S88 and ISA S95

• Pharmaceutical validation concept

• cGMP and GDP standards and GAMP Standards