Project Engineer MES / MIS

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

-

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.

-

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.

• 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.