Our client is looking to hire a MES Engineer to join our MES team. The selected candidate will be required to provide consultation and engineering service to the execution phase of the project. He/she will also be involved in the generation and ownership of IQ/OQ/PQ documentation and the GoLive Support.
· 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 NPI 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.
· Senior level Werum PAS-X experience; SME desired 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
· Self-starter who can get the job done despite obstacles
· Requires a Bachelor’s degree or foreign equivalent in Computer Science, IT, Technologies, Chemical Engineering, or Biologics related field
· Minimum 5 years’ experience as an MES, Application or Software Engineer, or related occupation