Process Validation Expert

Main Responsibilities: 

• In this position you are the focal point for defining the process validation strategy and its subsequent implementation for technical transfers of new processes.
• Further tasks include writing and approving documents related to process validation as a whole (risk analysis, protocols, reports) as well as documents related to studies of leachables and providing strong technical expertise to support routine production for trouble-shooting and complex investigations.
• In addition, you ensure scientific and regulatory monitoring related to process validation and thereby participate in continuous improvement of process and quality (e.g. Quality by Design).
• You are expected to execute your assigned projects in a timely manner, communicate actively within the unit and project management, timely deliver high quality documents and ensure scientific, technical and regulatory state of the art knowledge.

Requirements: 

• PhD in Biochemistry, Biochemical Engineering, Biotechnology, Chemistry or related sciences
  
• At least 3 years of relevant experience in GMP development and/or production in an industrial biopharmaceutical setting
  
• Strong experience in process validation
  
• Very good knowledge of English
  
• Good knowledge in French (oral & written) would be an asset

If you are a good team player with strong communication skills, good management skills with respect to priority setting and adherence to project timelines then you are exactly what we are looking for. Apply today either through the online portal or via email.

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