Electronics engineer (R&D)

Level: A Levels + 5

Under the responsibility of the technical manager, you will ensure within a multidisciplinary study team, the design of an electronic system and the monitoring of its realisation (Production equipment, prototypes, new product development).

You have acquired a minimum of two years’ experience, preferably in the medical device and/or pharmaceutical industry.

Regulatory affairs engineer

Level: A Levels + 5

Reporting to the Quality & Regulatory Affairs Manager, you will actively participate in the regulatory policy.

Within these functions, you will create the homologation files, make the AMM filing as well as the monitoring of the registrations at the national and/or international level.

As the underwriter for the registration procedures, you will handle the answers to the questions from the authorities following the filing of variations and registrations according to the current and up to date guidelines (ISO 13485, FDA, etc.).

In liaison with the regulatory authorities and/or the certification bodies, you will ensure the regulatory and normative norms and will be responsible for the traceability and archiving of documents.

Finally, in a demanding environment, you will intervene in the management and the follow-up of the complaints and non-conformities and will set up the CAPA.

You have acquired a minimum of two years’ experience in a similar role.

Engineer qualification

Level: A Levels + 5

Affiliated to the Quality department, you will be responsible for the smooth running of activities related to the qualification / validation of equipment and processes.

At different phases of the project (Audit, call for tenders, follow-up, Commissioning / Qualification), you will bring technical solutions in accordance with the relevant current standards.

You will evaluate the regulatory approach of a validation project (FDA, GMP) regarding equipment, processes and utilities.

You will define and then implement master plans of Qualification / Validation (Validation Master Plan).

You will validate your qualification policy with your customers / contracted suppliers.
In addition, you will identify and justify the critical points to check through criticality analysis tools, and ensure project coordination for the qualification and validation part in the execution phase.

You will handle and manage the administration related to qualifications (drafting, approval, protocols executions, reports), and you will plan and monitor qualification activities.
Through this technical work, you will also evolve in project management, as well as in quality, planning and budget monitoring.

You have acquired a minimum of two years’ experience within the pharmaceutical and medical device industry in relation to qualification / validation of medical equipment.

Process engineer

Level: A Level + 5

Affiliated to the Engineering Manager, you will be responsible for the design and implementation of new processes and equipment within the production units.

Finally, you will take part in the support process during the various stages of commissioning, start-up and performance testing. (FAT/SAT/IQ/OQ/PQ)

You have acquired a minimum of two years’ experience preferably in the pharmaceutical industry and the medical device  in manufacturing process.

Continuous improvement engineer

Level: A Level + 5

As part of the continuous improvement department, you will be responsible for optimising industrial performances by successfully carrying out improvement and innovation projects.

You will conduct the necessary audits to assess industrial performances.

You will create an action plan with the aim to improve industrial processes.

You will ensure the implementation of improvement solutions.

You will plan for and pilot the process for changes.

You will be responsible for the training of new methods to the technical team.

You will be responsible for optimal management of the budgets for all of the continuous improvement projects.

You will have acquired a minimum of two years’ experience in a similar role preferably in the medical device and/or the pharmaceutical industry.