MS Process Engineer
vor 11 Stunden
CK QLS are looking for a senior process engineer to join a global pharmaceutical company, based in Neuchatel, on a contract basis for 12 months.
Position: MS Process Engineer Formulation, Fill and Finishing, Neuchatel
Duration: 12 months
Main Responsibilities:- Manufacturing support activities (deviation, process follow-up) - 45% of the responsibilities.
- Projects management - 45% of the responsibilities.
- Audit and Regulatory questions related activities - 10% of the 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.
- Minimum 3-5 years of experience in FF area for recombinant protein.
- 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 enable you to work with people at all levels.
- Ability to plan, multitask, and manage time effectively.
- Must display eagerness to learn, innovate, drive for solutions, and continuous improvement.
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