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MES/MIS Project Engineer

Profiel MES/MIS Project Engineer

Are you looking for a role where you can directly impact production quality and efficiency through advanced information systems?

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We are looking for a Project Engineer MES/MIS to develop, implement, and manage electronic batch records (eBRs) and data systems within pharmaceutical production environments. You will ensure these systems meet user requirements and comply with industry standards.

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Tasks & responsibilities:

  • Provide technical support for all issues related to eBRs and data flow setups in production systems.
  • Support the development, implementation, and continuous improvement of Manufacturing Execution Systems (MES) in production units.
  • Set up and revise eBRs in the MES system, including programming, building, and testing recipes.
  • Convert existing paper batch records to the MES system in collaboration with internal teams such as Production, MS&T, and QA/QC.
  • Facilitate changes to other manufacturing systems for the setup of new products and optimisation for current flows.
  • Define user specifications based on the "Voice of Customer" approach.
  • Design and create electronic batch records considering quality, costs, and deadlines.
  • Create Master Batch Records (MBR), Bill of Materials (BOM), and serialisation recipes in production IT systems.
  • Participate in the qualification and risk assessment processes.
  • Support and technically validate IT and automation solutions with the quality team.
  • Participate in the rollout of MES projects across various production units.
  • Update production documentation post-implementation of eBRs.
  • Provide training to MES system users in collaboration with the training department.
  • Manage deviations and change controls, ensuring adherence to deadlines and regulations.
  • Offer real-time problem-solving on the shop floor, implementing immediate corrective measures.
  • Facilitate technical knowledge transfer regarding MES/MIS to the shop floor staff.
  • Collaborate with process experts for continuous process improvement and handling deviations related to MES/MIS.
  • Participate in change management initiatives alongside the change champion and HR partners.
  • Ensure compliance with local regulations, procedures, and standards.

Vereisten MES/MIS Project Engineer

  • Bachelor's or Master's degree in Electromechanics.
  • OVer 5 years of experience in a similar role within a GMP (Good Manufacturing Practice) environment.
  • Proficiency in Dutch and a good command of the English language.
  • Available to start from June 2024.
  • Willingness to engage in regular travel and long-term commitment to project timelines and objectives.

Regio

BE Antwerpen

Publicatie datum

24.06.2024

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