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Process Engineer Mechelen Belgium,  

Biocartis (company)


Posted on : 18 June 2017

Project Description

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 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.  


Our offering
  • 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. 

Locations

2800 Mechelen Belgium

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