Job Description

Major Responsibilities:

• Performs aseptic qualification of manufacturing personnel (e.g. gowning, aseptic processing) in the training lab and on the shop floor in Grade B cleanrooms.
• Define specific aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions.
• Drives the Aseptic Oversight program by execution of manufacturing floor surveillance.
• Identify risks and opportunities in relation to contamination control and assist in follow-up initiatives for improvement in close cooperation with operators, QC and operations management.

Your profile:

• A Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
• Experience within the biological and/or pharmaceutical industry with relevant aseptic experience related to manufacturing.
• Good written and verbal communication skills in Dutch and English.
• You have a passion for training and are willing to work in Grade B cleanrooms.
• Aseptic processing experience clean rooms, nice to have is experience with working in biosafety cabinets.
• Knowledge of cGMP regulations and FDA/EU guidance related to aseptic manufacturing.
• Detailed knowledge of the shop floor manufacturing process.
• Highly organized and capable of working in a team environment with a positive attitude under some supervision.
• You like to explore new paths, to make full use of your knowledge and experience, as well as to expand it, so that new problems also get solutions.
• You see possibilities and you look for them, even when they are not immediately clear.
• You like to work in a team towards a common goal.
• You consider diversity an asset.
• You can deal with procedures and guidelines that require strict application, as well as situations where not everything is clear yet.