Contracting – Geel

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, …)

Your profile?

• 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.