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MS Process Engineer Formulation, Fill and Finishing
RandstadNeuchatel, Neuchâtel, CHVor 26 Tagen
StellenbeschreibungLead 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 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
Jobdescription
For ourclient, an international pharma company based in Neuchâtel, we arelooking for an MS Process Engineer Formulation, Fill andFinishing.
GeneralInformation :
- Start date : ASAP
- End date : 28.03.2025
- 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 :
45% - Manufacturingsupport activities (deviation, process follow-up)
45% -Projects
10% - Audit and Regulatory questionsrelated activities
Your profile :