Industrialisation Engineer

The Industrialization Engineer supports:

• (i) the development and verification of cartridge manufacturing processes, (ii) QC method development and validation of assay-specific test methods, and (iii) stability strategy and execution for new products — covering both internal menu and partner projects.

• transfer of processes and methods to operational teams (OMPS and QC Operations).

  Accountabilities

• Supports the development of the assay specific CAR manufacturing processes, QC method development & stability activities and their delivery according to required technical requirements, quality levels, project plan and budget;
• Supports, plans and monitors progress of the assigned development and/or LC OMPS projects;

• Supports the development of the assay specific CAR manufacturing process steps (e.g., liquid dispensing process qualification, drying process parameters and limits, collection and analysis of process data, in process controls)

  - Carries out, and supervises process trials

  - Verifies for the assay specific process steps if the process parameter settings lead to a stable and capable manufacturing process    

  - Ensures efficient knowledge transfer of the assay specific process steps to Process validation;

• Supports the QC Method Development & Stability during all phases of the Assay Development Projects 

  - Proposes, develops and validates QC methods, makes recommendations for the performance of experiments in QC areas, including equipment, summarizes analyses and interprets data in order to draw conclusions

  - Develops strategy for stability testing, QC test panels and implementation of test methods including transfer to and training of QC operations; 

• Ensures the proper and timely preparation of protocols, reports, technical reviews, risk analysis and other documents;
• Ensures compliance with national and international (CE–IVDR, FDA) regulatory requirements and other applicable guidelines; oversees quality reporting and documentation related to the development activities;
• Presents own work at in-house forums and at outside professional meetings; 
• Participates in discussions at assay development and inter-departmental meetings in order to share information, knowledge, ideas, process improvements and judgment to help establish efficient industrialization directions;
• Participates in troubleshooting activities for established test methods/processes 
• Continuously assesses development processes and identifies improvement opportunities.

Profile requirements

• Academic level in engineering, bio-analytical chemistry or equivalent through experience and/or training
• Min. 3 years of experience in Pharma, Biotech, Medical Devices and/or in the IVD industry in area of expertise
• Experience with manufacturing process and/or QC development activities in a GMP/GLP environment is strong asset
• Knowledge of risk management processes; experience with NCR/CAPA and change management processes in a quality management system environment.
• Applied knowledge of sample preparation, NA extraction and real-time PCR
• Excellent technical writing and reporting skills 
• Applied knowledge of design & development process
• Knowledge of assay specific manufacturing processes
• Applied knowledge of GLP
• Languages : fluency in Dutch and English

Our offering

We offer you an exciting job in a fast growing international and innovative environment where you can work with top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team. You will have freedom to shape your work and shape your job where you deem it necessary: we value your input.

We will offer a very market competitive compensation package which includes a Flexible Income Plan.