Troubleshoot and provide solutions for MES & ERP problems in recipe execution and recipe authoring.
Liaise with QA to provide approved change control documentation for all MES system changes.
Design, create, write and execute to a high-quality standard, test and validation protocols, risk assessments, and system documentation.
Design, create, write and/or make all required changes to MES & ERP Recipes, worksheets, equipment and material spec's including phase transition logic to a high-quality standard.
Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-around and fixes identified.
Work closely with IT regarding upgrades, patching, hardware support, security and system access and provide technical expertise in implementing upgrades and patching.
Liaise with Global MES on required system improvements.
Provide support to other MES system users as required to ensure business continuity.
Participate in MES projects from initiation to ensure MES system or hardware requirements are taken into consideration.
Ensure maintenance/replacement of MES hardware, printers, scales, scanners and bar-code labelers. Review for upgrades periodically.
Keep other MES Team Members up to date on MES changes Documentation of all activities in line with cGMP requirements.
Cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
Adheres to and supports all health and safety standards, procedures and policies.
Requirements
Requires a Bachelor's degree or foreign equivalent in Computer Science, IT, Technologies, Chemical Engineering or Biologics related field
Werum PAS-X product hands-on experience 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 in Werum PAS-X
Knowledge on Industry Standards S88 and ISA S95
Experience working on projects in the pharmaceutical and/or biotechnology industries knowledge of GAMP lifecycle and quality management processes employed in the pharmaceutical sector Excellent communication skills and collaborative with team members and external groups
