Biocartis is an innovative biotech company that develops versatile molecular diagnostic platforms for low to highly multiplexed detection of molecular-based biomarkers. The ease of use and operational characteristics of these diagnostic platforms will lower the entry barrier to molecular diagnostic testing. The company is based in Mechelen and Lausanne. Biocartis is a young organization with highly talented people who believe in doing the right thing the right way. They are driven by the challenge of working for a top entrepreneur in the biotech industry that keeps pushing its technology until it reaches a new level. It is an exciting environment, where working hard and having fun are equally important. Respect is the keyword in the organization. Biocartis values the opinion and the input of all its employees and believes in an open culture with lots of communication. In order to support the design, engineering, start-up, optimization and life cycle management of the manufacturing production system (facilities, equipment, processes, products, components) and reporting to the Technical Services Manager, Biocartis is looking for a: Process Engineer Biochemical Processes (Mechelen – full time – m/f) Purpose of the position: Implement the 'infrastructure' for Manufacturing (facilities, equipment, processes, products, components). Specific focus will be on operations processes such as (semi)automated assembly, packaging equipment, instrument and console assembly, product components (plastic parts, foils, filters, …), bonding processes (sealing, welding), packaging, storage and transport/distribution processes. Assure correct implementation and validation of manufacturing, storage and transport/distribution processes. Define related working instructions. These instructions and associated records should assure compliance of the operations with ISO 13485 and other relevant regulations and guidelines (incl. environmental and safety). Intensively collaborate and partner with third party suppliers of process equipment, components and services to: o Define user requirements o Challenge the equipment / component design and service offers o Prepare and lead the installation, qualification and acceptance of the manufacturing environment and process equipment. o (Co)-own the (master) validation plan for the manufacturing environment / equipment / system, and be responsible for the execution of this plan. o Support start-up and maintenance of equipment o Prepare and lead the introduction of components into the manufacturing environment. Together with QC department, define necessary QC procedures, e.g. incoming, in-line and outgoing inspections and associated record-keeping. Actively participate in (outsourced) product and process development sub-projects as a team member, and assure Biocartis' interests are sufficiently safeguarded. Support continuity of operations, problem analysis and resolution, implementation of next generation products/processes/systems. Identify efficiency improvement opportunities (product, manufacturing, organization, change-over-time, ergonomics & lean implementation) and evaluate the potential benefit. If appropriate, manage the development of the improvement opportunity and the implementation into the operation Actively participate in training of the manufacturing crew.