Contamination Control Engineer

il y a 4 semaines


Geel, Flandre, Belgique Arcadis Temps plein

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.


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