Publication date
13 July 2026
Department
R&D – Industrialisation
Location
Mechelen, Belgium (hybrid)
Work arrangement
Hybrid
Travel percentage
0%
Function type
Full-time
Contract type
Employee
Experience required
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
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
Education
Academic level in engineering, bio-analytical chemistry or equivalent through experience and/or training
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.
