MS Process Engineer Formulation, Fill and Finishing.

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