MSAT Process Expert
On behalf of our Pharmaceutical company in Neuchatel, we are looking for an MSAT Process Expert with experience in MSAT Activities in the area of Fill & Finish for a long-term contract of 12 months, with a high possibility of extension.
General Information:
Duration: 12 months
Location: Neuchatel
Hybrid role: 2 days per week on site, but the first 2/3 weeks on site full time to get to know the team.
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 FF process or equipment (from User Requirements Specifications to Process Performance Qualification).
* Support validation activities.
* Support or present topics during regulatory inspections.
* Support technology transfer.
Education and Experience
* Minimum 3-5 years of experience in the 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.
Key Skills, Abilities, and Competencies
* Strong energetic 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.
* 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 continuously improve.
* Able to work in a matrix environment and manage complex problems.
If this job interests you, please send us your CV today through the link in the advert. However, should you have any questions, please contact Elaine Kanwar at elaine.kanwar(at)experis.ch or at +41 61 282 22 23.
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