Biocartis is a privately owned biotech company that engages in the development of novel diagnostics technology platforms for low to highly multiplexed detection of molecular-based biomarkers. Biocartis is based at the EPFL Science Park in Lausanne (Switzerland), at the High Tech Campus in Eindhoven (The Netherlands) and is setting up a manufacturing and assay development facility in Mechelen (Belgium).
Production Engineer (Process) Job Description
For the design, engineering, start-up and optimization of the cartridge manufacturing production system, we are looking for a pragmatic, experienced process engineer.
Principal Contributions / Accountabilities and Associated Activities
- Implement the ‘infrastructure’ for Cartridge Manufacturing (facilities, equipment, processes, products, components).
More specifically : - Intensively collaborate and partner with third party suppliers of process equipment and components to :Specific focus will be on (semi)automated assembly and packaging equipment and product components (plastic parts, foils, filters, …)
- Define user requirements
- Challenge the equipment / component design
- Prepare and lead the installation, qualification and acceptance of process equipment in the manufacturing environment.
- (Co)-own the (master) validation plan for the manufacturing 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
- Together with QC department and purchasing department, define supplier quality requirements, and method of control and documentation
- 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)
- Specific focus will be on bonding processes (sealing, welding), packaging, storage and transport/distribution processes
- 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 improvement opportunities (product, manufacturing or assembly process, assembly equipment, organization) 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
The Process Engineer reports to the Head of Technical Operations or ad interim to the Director Cartridge Manufacturing.
Production Engineer (Process) Job Requirements
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You are a 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
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You preferably have 5 years or more relevant experience in the pharmaceutical, medical devices or diagnostics industry
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Experience with IVD manufacturing processes, preferably in the field of nucleid acid related products (Biochemical processes) is an asset
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Knowledge of ISO 13485 and cGMP manufacturing
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Process development, manufacturing equipment development and automation experience and expertise
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IQ/ OQ/ PQ / qualification knowledge
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Experience with definition and purchasing of manufacturing equipment (CAPEX)
Behavioral Competencies
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Organizational and planning skills
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Looking across the boundaries of your own responsibilities and expertise
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Self-propelling, hands on mentality, pragmatic approach
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People skills, able to communicate to all layers in the organization
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Good communication skills in Dutch and English, preferably also in German
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Flexibility, not a 9-to-5 mentality, able to work under stress
Production Engineer (Process) Application Information
Are you interested in this opportunity? Do you have additional questions? You can contact Anne Thyssens. Please apply with your CV and cover letter by the 'apply' button below.
Our offer
We 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 a responsible job with freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.
Production Engineer (Process) Summary
Education Backgrounds: |
Biomedical Science Chemical Engineering Mechanical Engineering |
Specialties: |
Pharmaceutics Process Management
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Education Level: |
Undergraduate (Bachelors) Postgraduate (Masters)
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Experience: |
10 - 15 years 5 - 10 Years > 15 years
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Languages spoken: |
English |
Job Location: |
Mechelen, Belgium |
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