Process Engineer

il y a 9 heures


Mechelen, Belgique Biocartis Temps plein

As Process Engineer – Liquid Specialist at Biocartis, you are responsible for all liquid-related manufacturing processes within our state-of-the-art, highly automated production environments. This includes the preparation of Spots Solutions, Buffers and Reagent, as well as the dispensing and drying operations that are critical to our final product: the Cartridge.In this role, you act as the central expert for liquid processes in the production environment. You continuously monitor, control, and optimize these processes to ensure robust performance, product quality, and operational efficiency, working in close collaboration with cross-functional teams.AccountabilitiesAs Process Engineer – Liquid Specialist, you are responsible for the following:1. Liquid Manufacturing Process Specialist• Act as the process owner for the entire liquid (Wet BOM) workflow: from order intake to final cartridge manufacturing; including all related aspects such as PQA and criticality assessments.• Lead the Release for Manufacturing activities for new or updated liquid formulations.• Serve as the primary interface between Product Development (OMPS) and Manufacturing, ensuring the correct and robust implementation of new products and processes.• Act as owner of Non-Conformances and CAPA's related to the liquid manufacturing processes.2. Liquid Manufacturing Equipment Specialist• Serve as the process owner for all liquid-handling operations (pipetting, dispensing, filling, drying, volume control, etc.) and manage associated QMAP, pFMEA, and validation activities in full compliance with GMP requirements.• Act as equipment owner, overseeing the complete equipment lifecycle—including new system introduction, performance improvements, calibration requirements, and qualification activities.• Drive continuous improvements, changes, and upgrades for all liquid manufacturing equipment.• Own and maintain all equipment recipes, both in documentation and within the production environment.• Serve as owner of Batch Records and all other manufacturing documentation related to liquid-handling equipment.Profile requirementsMaster's degree in engineering and/or equivalent through experience.3-5 years of work experience within medical devices, pharmaceuticals, chemical or in-vitro diagnostics. Experience with process improvement projects is an asset.Technical knowledge of manufacturing equipment is considered a plus. Our offeringWe offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a competitive compensation package which includes a Flexible Income Plan.


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