Overview 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.
Responsibilities Responsibilities:
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
Qualifications 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
Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click HERE to read more in our 2022 Corporate Responsibility and Health, Safety and Wellbeing Report.