MSAT Process Expert
We are seeking an experienced MSAT Process Expert to support our Pharmaceutical company in Neuchatel.
General Information:
Duration: 12 months
Location: Neuchatel (hybrid role: 2 days per week on site)
Primary Duties
* 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.
* Lead projects or activities related to Fill & Finish (FF) process or equipment.
* Support validation activities.
* Support or present topics during regulatory inspections.
* Support technology transfer.
Education and Experience
* Minimum 3-5 years of experience in the Fill & Finish 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.
Key Skills, Abilities, and Competencies
* Strong team player with good communication skills.
* Ability to lead effectively and efficiently on process validation topics.
* Ability to manage multiple priorities in a manufacturing plant setting.
* Ability to analyze, review, and interpret validation data.
* Uncompromising dedication to quality and 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.
* Eagerness to learn, innovate, drive for solutions, and continuously improve.
* Ability to work in a matrix environment and manage complex problems.