MES Engineer Snr.
About the role:
Our client is currently looking to hire Senior MES Engineers (Werum PAS-X) to join our Ireland MES Projects Team, supporting multiple projects with the worlds leading Pharmaceutical and Biotech companies.
- 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 other automation systems using standard interface component of MBR design.
- 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.
- 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.