MS Process Engineer Formulation, Fill and Finishing
Randstad (Switzerland) Ltd.
Veröffentlicht:
19 November 2024Pensum:
100%- Arbeitsort:Neuchatel
job details
For our client, an international pharma company based in Neuchâtel, we are looking for an MS Process Engineer Formulation, Fill and Finishing.
General Information:
Tasks and responsibilities:
45% - Manufacturing support activities (deviation, process follow-up)
45% - Projects
10% - Audit and Regulatory questions related activities
Your profile:
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
