MS Process Engineer
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.
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 (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.
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 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.
Apply:
If you are interested, you can send a CV in English to aguimard@ckqls.ch. Please quote job reference 108 313 in all correspondence.