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.
- 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 company 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.
- 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 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
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