The Contamination Control Engineer performs/supports the performance of the following activities related to the assigned product(s) as per procedures:
1) 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.
2) 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.
3) 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
4) Support site improvement projects as Contamination Control (Launch platform for new clinical products, EFA ramp-up, Dupilumab acceleration, …)
REQUIREMENTS
Education / Experience
• Master’s degree or equivalent in Pharmaceutical/ Biotech/ Life sciences.
• Preferably 1- 3 years’ experience in the pharmaceutical industry of manufacturing and/or quality operations.