This job is currently Archived,
Posted on : 18 June 2017
Purpose of the position: Support the design, engineering, start-up, optimization and life cycle management of the manufacturing production system (facilities, equipment, processes, products, components). The Process Engineer is part of the Line & Capacity Availability team. Accountabilities: 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 :- Define user requirements- Challenge the equipment / component design and service offers- Prepare and lead the installation, qualification and acceptance of the manufacturing environment and process equipment.- (Co)-own the (master) validation plan for the manufacturing environment / equipment / system, and be responsible for the execution of this plan.- Support start-up and maintenance of equipment- 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. Profile & Competencies: Master or Bachelor in a relevant technical area, e.g. mechanical engineering, chemical engineering, bio-chemistry or you have achieved a similar level by experience; Preferably 5 years or more relevant experience in the pharmaceutical, medical devices or diagnostics industry; Six Sigma Green belt certified is a plus; Experience with IVD manufacturing processes, preferably in the field of nucleid acid related products (Biochemical processes) is an asset; Familiar with ISO 13485 and cGMP manufacturing; Process development, manufacturing equipment development and automation experience and expertise; Knowledge of IQ/ OQ/ PQ / qualification; Experience with definition and purchasing of manufacturing equipment (CAPEX); Worked within new Product Development Teams on the industrialisation, transfer to manufacturing and production ramp up of new products; Good knowledge of Dutch, English and/or German; MS Office; Project specific Applications; Result oriented and driven; Teamplayer and eager to learn; Flexible and pro-active mindset. 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 fitting compensation package.
2800 Mechelen Belgium
Find a Job Find Candidates