Ms process engineer
vor 4 Wochen
MS Process Engineer Formulation, Fill and Finishing, Neuchatel Duration: 12 month Main Responsibilities: Manufacturing support activities (deviation, process follow-up) 45% of the responsibilities.
Projects management represents 45% of the responsibilities.
Audit and Regulatory questions related activities represents 10% of the responsibilities.
Further Responsibilities: Lead process improvement projects or activities.
Develop and optimize process parameters.
Ensure process performances through Quality by Design (Qb D) 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.
Candidate’s requirements: Minimum 3-5 years of experience FF area for recombinant protein.
Engineering or university degree in biotechnology.
Language skills: Fluent in English and French.
Knowledge of c GMP 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 c GMPs 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.
Apply: If you are interested, you can send a CV in English to Please quote job reference 108 313 in all correspondence.
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