MES (PAS-X) Engineer - Dublin, Ireland

  • Company: Confidential - 212014708
  • Job Location: Dubli - Ireland
  • Date: May 11, 2020 21:46
  • Employment Type: contract
  • Experience: Any
  • Job Functions:

Job summary

MES (Werum PAS-X) Engineer

* Create business process flow diagram for pharmaceutical product recipes based on the paper batch record or source documents

* Gather MES Site specific requirement...

Job description

MES (Werum PAS-X) Engineer

* 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

Qualifications/ Requirements:

* Bachelor’s Degree in engineering / science

* 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

* Team skill

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