MS Process Engineer Formulation, Fill and Finishing
Jobdescription
For ourclient, an international pharma company based in Neuchâtel, we arelooking for an MS Process Engineer Formulation, Fill andFinishing.
GeneralInformation :
- Start date : 06.01.2025
- Enddate : 31.12.2025
- Workplace : Neuchâtel
- Workload : 100%
- Home office : possible up to 3 daysper week, but during the first 2-3 weeks onsite presence requiredfull time
Tasks andresponsibilities :
- Lead processimprovement projects or activities
- Develop andoptimize process parameters
- Ensure processperformances through Quality by Design (QbD) and Continuous ProcessVerification (CPV) approaches
- Identify businessopportunities
- Ensure communication and actproactively in case of performancetrending
- Lead and / or support investigationsrelated to deviation / CAPA process
- Performproduct impact assessment for deviation
- Leadprojects or activities related to FF process or equipment (fromUser Requirements Specifications to Process PerformanceQualification)
- Support validationactivities
- Support or present topic duringregulatory inspections
- Support technologytransfer
45% - Manufacturingsupport activities (deviation, process follow-up)
45% -Projects
10% - Audit and Regulatory questionsrelated activities
Your profile :
- Minimum 3-5years of experience FF area for recombinantprotein
- Previous MSATexposure
- Engineering or university degree inbiotechnology
- Language skills : Fluent inEnglish and French
- Knowledge of cGMP andquality requirements
- Able to deal withstatistics
- Strong energetic team player withgood communication skills
- Ability to leadeffectively and efficiently process validationtopics
- Ability to manage multiple priorities ina manufacturing plant setting
- Ability toanalyze, review and interpret validationdata
- Must have uncompromising dedication toquality and an excellent understanding of cGMPs and otherregulatory guidelines
- Interpersonal skills thatenables you to work with people at alllevels
- Ability to plan, multitask, and managetime effectively
- Must display eagerness tolearn, to innovate, drive for solutions and continuouslyimprovement
- Able to deal in a matrixenvironment as well manage complexproblem
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