Validation Specialist

4 weeks ago


Chicago, Illinois, United States Sterling Engineering Inc. Full time

h3JobDescription/h3pAtSterlingEngineeringInc.,weareseekingaskilledbValidationSpecialist/btojoinourteaminthecommissioning,validation,andqualificationofequipment,facilities,andutilitieswithinapharmaceuticalmanufacturingenvironment./ppbKeyResponsibilities:/b/pulliDevelopandimplementequipment/facility/utilityandinstrumentqualificationprotocols,aswellasvalidation/qualificationpolicies./liliInitiatechangecontrolsandprovidevalidationassessmentsandremediationplansasrequiredbythesystem/equipment/components./liliDesignandexecutecommissioningandqualificationplans./liliDevelopURS,FS,DQdocumentsandqualificationprotocols(IQ/OQ/PQ)toensurecompliancewith21CFRPart210and211,aswellasadherencetoICHQ7./liliParticipateinrisk-basedevaluationsandprovidetechnicalinputduringFMEAprocesses./liliEnsurecompliancewithFDAandEUregulations./liliEvaluate,document,anddevelopinvestigationsattributedtoqualificationsfailures./liliAuthorsummaryreports,events,andapplicableprotocolamendments./liliExecuteand/orprovidesupportduringprotocolexecutions./liliTrackandensuresuccessfulcompletionofallqualificationitems./liliPerformgapanalysisandproviderecommendationsforexistingqualifications./liliValidation/qualificationactivitieswillcoversoftware,automatedsystems,laboratoryinstruments,productionequipment,packagingsystems,andfacilityutilities(HVAC,Water,etc.)./li/ulpbRequirements:/b/pulliBachelor'sorMaster'sdegreeinEngineering,Science,orarelatedfield./lili3+yearsofexperiencewithcommissioning,validation,andqualificationofequipment/facilities/utilitiesandprocessesusingarisk-basedapproachandleveragingstrategies.Temperaturemappingisaplus./liliPharmaceutical,healthcare,ormedicaldeviceindustryexperienceisaplus./li/ulpemQualifiedapplicantswillreceiveconsiderationforemploymentwithoutregardtorace,color,age,religion,sex,sexualorientation,genderidentity,nationalorigin,disability,protectedveteranstatus,orgeneticinformation./em/p



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