MS Process Engineer Formulation, Fill and Finishing

Jobdescription
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

Marta Tomczyk