Beschreibung

For our client, an international pharma company based in Neuchâtel, we are looking for an MS Process Engineer Formulation, Fill and Finishing.


General Information:
 

• Start date: 06.01.2025
• End date: 31.12.2025
• Workplace: Neuchâtel
• Workload: 100%
• Home office: possible up to 3 days per week, but during the first 2-3 weeks onsite presence required full time
  
  Tasks and responsibilities:
   
  • Lead process improvement projects or activities
  • Develop and optimize process parameters
  • Ensure process performances through Quality by Design (QbD) and Continuous Process Verification (CPV) approaches
  • Identify business opportunities
  • Ensure communication and act proactively in case of performance trending
  • Lead and/or support investigations related to deviation/CAPA process
  • Perform product impact assessment for deviation
  • Lead projects or activities related to FF process or equipment (from User Requirements Specifications to Process Performance Qualification)
  • Support validation activities
  • Support or present topic during regulatory inspections
  • Support technology transfer
    45% - Manufacturing support activities (deviation, process follow-up)
    45% - Projects
    10% - Audit and Regulatory questions related activities
    
    
    
    Your profile:
     
    • Minimum 3-5 years of experience FF area for recombinant protein
    • Previous MSAT exposure
    • Engineering or university degree in biotechnology
    • Language skills: Fluent in English and French
    • Knowledge of cGMP and quality requirements
    • Able to deal with statistics
    • Strong energetic team player with good communication skills
    • Ability to lead effectively and efficiently process validation topics
    • Ability to manage multiple priorities in a manufacturing plant setting
    • Ability to analyze, review and interpret validation data
    • Must have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelines
    • Interpersonal skills that enables you to work with people at all levels
    • Ability to plan, multitask, and manage time effectively
    • Must display eagerness to learn, to innovate, drive for solutions and continuously improvement
    • Able to deal in a matrix environment as well manage complex problem