Responsibilities: The Contamination Control Engineer performs/supports the performance of the following activities related to the assigned product(s) as per the companies procedures:
- Microbial control of process, cleanroom and clean utility:
- Ensures microbial control of process, cleanroom and clean utility systems by setting up monitoring plans, setting limits, perform trend evaluations, define improvement actions.
- Delivering Performance qualification documents for clean utility and cleanroom systems.
- Perform trend evaluation and reporting of microbial data for process, cleanroom and clean utilities.
- Deviations and Change Controls:
- Perform investigations as coordinator and/or investigation leader for deviations related to process, clean utility or cleanrooms.
- (Pre-)Asses the microbial impact of proposed changes
- Provide microbial information as part of deviation to further assess the impact on product.
- Elaborate the overall Contamination Control strategy within the site.
- Transversal activities:
- Actively participate in awareness and training sessions regarding Contamination Control for the Geel site.
- Acts as the contact person with regards to Contamination Control expertise.
- Participate and supports in site inspections and audits
- Support site improvement projects as Contamination Control (Launch platform for new clinical products, EFA ramp-up, Dupilumab acceleration, …)