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 (open to commute or relocate)

Duration: 12 months.

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 in this role, you can send a CV in English to aguimard@ckqls.ch. It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 110 799 in all correspondence.