Project Engineer MES / MIS

at  PM Group

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To support an important project at a client in the pharmaceutical sector PM Group is searching for an experienced PROJECT ENGINEER MES / MIS to reinforce the OTS (Outsourced Technical Services) team.
This assignment is open for employees and freelancers.
PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of 3,700 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors.
Our Vision is to be a highly valued and creative delivery partner, building a more sustainable world with our clients. To do this our people are key and is where you can play a part.
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QUALIFICATIONS:

• Bachelor of Master Electromechanics
• > 5 years of experience in a similar role
• experience in a GMP environment
• Available from June ’24
• Dutch speaking with a good knowledge of English

Tasks:

• providing technical expertise to support all issues related to electronic batch records (eBRs) and/or data flows and setup in the various systems used in the production environment
• supporting the development, implementation, and continuous improvement of MES in production units and provides routine technical support on the shop floor.
• is responsible for setting up and revising electronic batch records in the MES system (programming, building, and testing recipes), as well as converting some existing products from a paper batch record to the MES system (in close collaboration with internal stakeholders such as Production, MS&T, and QA/QC is essential to ensure that user requirements are appropriately integrated)
• provides support for necessary changes to other manufacturing systems for the setup of new products as well as the optimization of current flows.

Key Activities:

• Define required user specifications ("Voice of Customer")
• Design and create electronic batch records (EBRs) considering quality, costs, and deadlines
• Create MBR/BOM/serialization recipes in production IT systems
• Participate in qualification and risk assessment processes
• Support the choice of solutions proposed by IT teams and Automation and technically validate them with the quality team
• Participate in the rollout of MES projects in various production units, in close collaboration with the production units
• Update production documentation after the implementation of electronic batch records and requirements
• Provide training for MES users in collaboration with the training team
• Ensure follow-up and processing of deviations and change control while adhering to deadlines and applicable regulations
• Provide real-time problem-solving on the shop floor with the implementation of appropriate immediate corrective measures
• Ensure information transfer to production teams after issues or modifications with technical impact or impact on quality or HSE
• Provide technical knowledge transfer regarding MES/MIS to the shop floor
• Collaborate with process experts in the context of deviations related to MES/MIS and continuous process improvement
• Participate in change management in close collaboration with the change champion and HR partner
• Ensure compliance with local regulations, procedures, and guidelines

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