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