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MS Process Engineer Formulation, Fill and Finishing

Posted: 02 Dec 2024

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Engineering
Neuchâtel
English

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
  • Kledge 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