Jobdescription
Forourclient,aleadingpharmaceuticalcompanyinSwitzerland,wearelookingforaValidationExpert.
GeneralInformation:
* Startdate:ASAP
* Lateststartdate:01.09.2025
* Duration:unlimited
* Workplace:Kaiseraugst
* Workload:100%
* Team:20people
* Department:EngineeringScienceandTechnology(MMMCG)
* Workinghours:Standard
* On callduty:Yes,throughouttheyear
Aboutthejob:
TheCenterofExcellenceCleaningValidationisresponsibleforscientificallydemonstratingthatthecleaningprocessofproductcontactproductionequipmentcanremoveallresiduestoensurethatnocross contaminationoccurs.Validationisbasedontoxicologicaldata,sling,andanalysisofslesinourlaboratoriesusingtechniquessuchasHPLC,ELISA,TOC,andMS.Thetraceanalysisusedisbothdevelopedandvalidatedin house.OurclientscustomersspanallvaluestreamsinKaiseraugst,BaselBiotech,andpartsoftheIMPsector.AttheCleaningValidationCompetenceCenter,youhavenumerousopportunitiesforfurthertraining,aswehaveclosetiestopharmaceuticalproductionandarealsoacenterofexcellencefortraceanalysis.
Tasks&responsibilities:
* Collaborationwithinternalandexternalinterfaces(especiallylaboratoriesandvaluestreams),practicalimplementationanddocumentation ofallcleaningvalidationsletrainsintheplants
* Sling,slepreparation,compilation,evaluationanddocumentationoftheresultsofthecleaningvalidationsletrainscarriedout
* Creating/maintainingplans,reports,sletrainprotocolsandSOPs
* Ensuringtimelycleaningvalidationactivitiesincompliancewithall GMPrequirementsandprocesses
* EnsuringthatcustomerrequirementsinproductionaremetinrelationtotheRV
* Riskassessmentsonthesubjectofcleaning
* ADCmonitoring,spillandsmallscalestudies,cleaningassessments
* Launches/techtransfersintheareaof??cleaningvalidations
* Troubleshootingincleaning relatedproductionprocesses,conductingrootcauseanalyses,creatingproductqualityimpactassessments
* DOCSPOC,SMEforPQSdocuments
* Supportingsuggestionsforimprovementandprocessoptimizations
* CompliancewithSGUguidelines
* Supportingteamspiritandteamworkforindependentwork
* Ensuringasufficientflowofinformationwithintheteamandwithinterfaces
MustHaves:
1. Min.completedvocationaltraining,universitydegreepreferred
2. Min.2yearsofpracticalprofessionalexperienceintheareaofcleaningvalidationwithinapharmaceuticalproduction,particularlyinhandlingsles
3. Min.2yearsofprofessionalexperienceinaGMPregulatedworkingenvironment
4. Experienceininterf