About the position
To support the continuous improvement of our existing production unit and the expansion of our Manufacturing production unit, we are looking to strengthen our operations team with a Project/Process Engineer.
In taking up this job you are responsible for the execution of technical equipment and utility projects, manufacturing process development and optimizations.
Furthermore, you will qualify and document activities related to implementation and optimalisation of equipment/utility and to manufacturing process development and optimizations
Your key tasks will be to:
- set up project planning and actively coordinate/execute the project progress within the defined timelines and quality requirements;
- complete the validation cycle for equipment and utilities from URS, risk analysis up to writing and execution of validation protocols for IQ, OQ, and PQ;
- complete the cycle for process development, starting with study report, and followed by process validation;
- provide delivery of process development, process qualification and process validation deliverables ensuring efficient manufacturing with quality output;
- train operators in the use of new equipment / execution of new processes;
- communicate and report in a timely manner on the progress, issues and risks to the Manufacturing Manager;
- document all relevant project/process data according to GDP requirements;
- write procedures and work instructions.
- A motivated graduate (master level) with good planning and documentation skills and a first work experience in project execution in a GxP environment.
- Commissioning and validation-knowledge for manufacturing equipment (including writing and execution of validation-documentation) is a plus.
- Knowledge of data analysis.
- Fluent Dutch speaker, able to communicate and write in English.
- Hands-on mentality: likes to be on the floor and working on equipment.
- first think, then act – and documents actions.
- eager to learn and to think about the best/pragmatic way to execute the testings and qualifications.
Up for the challenge? We welcome your cv + motivation letter at firstname.lastname@example.org.
By joining Fujirebio you contribute to a better healthcare in a company where different cultures meet each other which makes our jobs challenging and stimulating.
Our employees appreciate their rich job content and the great deal of independence within their job.
In an open, informal and dynamic work environment you will be collaborating with our scientific, commercial, operational and supportive teams. To support this collaboration and to support personal growth of all team members we offer our employees the opportunity to develop their knowledge, skills and talents.
Our committed and engaged employees make that Fujirebio Europe (previously Innogenetics) provides innovative solutions for healthcare all over the world.
Our products and services allow doctors to make fast and accurate diagnosis in different disease fields like infectious diseases (f.e: Hepatitis C, HIV), neurological disorders (f.e. Alzheimer’s disease), oncology and genetic diseases (f.e. mucoviscidose). Based upon this specific an accurate testing, appropriate treatment can be started quickly.
We develop and manufacture diagnostic tests at our site in Ghent, as well as in Tokyo, after which they are sold worldwide by our commercial teams to hospitals and clinical labs.
Furthermore, we use our advanced experience in development and manufacturing of Diagnostic solutions and our high-quality standards for contract manufacturing projects with third parties.
Fujirebio Europe belongs to an international group (H.U. Group) with branches and colleagues in Asia, Europe and the USA. We currently employ 130 people at the headquarters in Ghent and more than 40 people in our European affiliates.