Project / Process Engineer
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 validation (including cleaning validation).
Furthermore, you will validate and document activities related to implementation and optimalisation of equipment/utility and manufacturing processes.
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 System Requirement, 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;
- execute validation activities (equipment, process, cleaning, etc) ensuring efficient manufacturing with quality output;
- train operators in the use of new equipment / execution of new processes;
- act as system matter expert in close collaboration / communication with Manufacturing teamleaders and operators;
- communicate and report in a timely manner on the progress, issues and risks to the Manufacturing Manager or Sr Project Engineer;
- document all relevant project/process data according to GDP requirements;
- write procedures and work instructions.
Your Profile
- A motivated graduate (master level; 3-5 years experience) with good planning and documentation skills and experience in project execution in a GxP environment.
- Commissioning and validation-knowledge for manufacturing equipment (including writing and execution of validation-documentation) and processes.
- 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, executing processes and first think, then act – and documents actions.
- Eager to learn and to think about the best/pragmatic way to execute the testings and qualifications.
Our Offer
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.
About us
Our committed and engaged employees make that Fujirebio Europe (previously Innogenetics) provides innovative IVD 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, neurological disorders and some rare diseases. Based upon our high-quality testing, appropriate treatment can be started quickly. We strive at being the best in each disease field in offering the best and unique diagnostic solution.
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 145 people at the headquarters in Ghent and 50 people in our European affiliates.
