MES Engineer - Consultant / PAS-X (m/w/d)
Job Summary : Responsibilities
Shift : Roles & Responsibilities :
- Create business process flow diagram for pharmaceutical product recipes based on the paper batch record or source documents.
- Gather MES Site specific requirement analysis to develop URS and FRS.
- Logically breakdown the recipes/Mfg. process to configure the recipe in to Werum PAS-X
- Develop/create MBR design elements (building blocks) and workflows in Werum PAS-X for repetitive use in MBR creation to expedite the process.
- Gather master data and configure in Werum PAS-X Development/Quality/Production Environment.
- Integrating Werum PAS-X with SAP and automation systems using standard interfaces.
- 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. Requirements
- A Bachelor's degree in Computer Science Computer Engineering Computer Information Systems or a related field (Technology Management Chemical Engineering)
- Senior level Werum PAS-X experience desired
- Total 5+ years of hands-on experience on MES Product Min 2+ years in MBR designing role.
- Werum PAS-X 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 Werum PAS-X
- Knowledge on Industry Standards S88 and ISA S95
- Pharmaceutical validation concept
- cGMP and GDP standards and GAMP Standards
- Good verbal written communication.
Demand requires Travel? : Certification(s) Required :
- Understand business requirements conduct detailed gap analysis of a product versus the requirements create the functional design acts as the functional SME for a module own the business process flows for the customer perform product configuration setup WITH THE OBJECTIVE of ensuring complete coverage.