Project Engineer MES / MIS Puurs (BE)

Vacature in het kort

Seeking a Project Engineer MES/MIS to revolutionize pharmaceutical production with advanced electronic batch records and data systems. This role involves developing, implementing, and managing systems to enhance production quality and efficiency, ensuring compliance with industry standards. Responsibilities include technical support, system improvement, recipe programming, and training. A unique opportunity to directly impact production processes and drive innovation in a dynamic environment. Read on to see how your skills fit into this role.

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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.

Gevraagd

• 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.