Engineer, Computer Software Assurance

Accountabilities

• LeadthedevelopmentandexecutionofcomprehensiveComputerSystemValidation(CSV)andComputerSoftwareAssurance(CSA)strategies,plans,andprotocols,includingInstallationQualification(IQ),OperationalQualification(OQ),andPerformanceQualification(PQ).

• OverseevalidationactivitiesforGxP-regulatedcomputerizedsystems,includingenterpriseresourceplanning(ERP)platforms,qualitymanagementsystems(QMS),manufacturingexecutionsystems(MES),manufacturingequipmentsoftware,dataintegritysystems,andcustomapplications.

• Ensurecomputerizedsystemscomplywithapplicableregulatoryrequirements,includingFDA21CFRPart820,21CFRPart11,ISO13485,andotherrelevantglobalstandards.

• Develop,review,andmaintainvalidationdocumentation,includingUserRequirementsSpecifications(URS),designspecifications,validationplans,traceabilitymatrices,qualificationprotocols,summaryreports,andcontrolledprocedures.

• Applyrisk-basedvalidationmethodologiestoassesssystemfunctionality,identifycompliancegaps,andestablishappropriateverificationandtestingstrategies.

• Ensuredataintegrity,electronicrecords,electronicsignatures,audittrails,andsystemsecuritycontrolsmeetregulatoryandorganizationalrequirements.

• CollaboratewithIT,QualityAssurance,Engineering,Manufacturing,andotherstakeholderstosupportcompliantsystemimplementations,upgrades,andlifecyclemanagement.

• ProvidetechnicalguidanceonvalidationbestpracticesandcontributetothedevelopmentandimprovementofCSV,CSA,andqualitymanagementprocesses.

• Supportregulatoryinspectionsandauditsbypreparingvalidationdocumentation,addressingfindings,andprovidingsubjectmatterexpertisewhenrequired.

• Stayinformedaboutevolvingregulatoryexpectations,validationmethodologies,andemergingtechnologiestoimprovecomplianceandoperationalefficiency.

Requirements

• Atleast5yearsofexperienceinComputerSystemValidationwithinaregulatedmedicaldevice,pharmaceutical,biotechnology,orcomparablelifesciencesenvironmentispreferred.

• AdvancedknowledgeofFDA21CFRPart11,21CFRPart820,ISO13485,ISO14971,GAMP5guidelines,andFDAguidanceonrisk-basedsoftwarevalidationandComputerSoftwareAssurance.

• Demonstratedexperienceleadingtheplanning,execution,anddocumentationofvalidationactivitiesforenterpriseandmanufacturingsystems.

• Provenabilitytodevelopandmaintaincomprehensivevalidationdocumentation,includingURS,designspecifications,traceabilitymatrices,validationplans,IQ/OQ/PQprotocols,summaryreports,andstandardoperatingprocedures.

• Strongunderstandingofdataintegrityprinciples,audittrails,electronicrecordsandsignatures,andcomputerizedsystemsecurity.

• Excellentanalytical,problem-solving,technicalwriting,andcommunicationskills,withtheabilitytoexplaincomplextechnicalandregulatoryconceptsclearly.

• Strongorganizationalskillsandtheabilitytomanagemultiplevalidationactivitieswhilemaintainingaccuracy,documentationquality,andregulatorycompliance.

• Abilityandwillingnesstotravelasrequired.

Preferred qualifications:

• FamiliaritywithEUMedicalDeviceRegulation(EUMDR),EUGMPAnnex11,andISO27001informationsecuritystandards.

• Hands-onexperiencevalidatingcloud-basedplatformsandSoftware-as-a-Service(SaaS)applications.

• ExperiencesupportingFDAinspectionsandNotifiedBodyauditsasaComputerSystemValidationsubjectmatterexpert.

• Experiencedeveloping,standardizing,orimprovingCSV,CSA,andQualityManagementSystemprocesses.

• Abilitytocollaborateeffectivelywithglobalteamsandcontributetocontinuousimprovementinitiativesinregulatedenvironments.

Benefits

• Competitivebenefitspackagedesignedtosupportemployeehealth,financialwell-being,andwork-lifebalance.

• Healthcarebenefitsandadditionalemployeesupportprograms,subjecttolocation-specificpolicies.

• Paidtimeofftosupportpersonalneedsandwell-being.

• Potentialremote-workflexibility,withthespecificarrangementtobeconfirmedduringrecruitment.

• Professionaldevelopmentopportunitiesincomputersoftwareassurance,regulatorycompliance,andvalidationofmodernenterpriseandmanufacturingtechnologies.

• Cross-functionalcollaborationwithexperiencedprofessionalsinquality,engineering,IT,andmanufacturing.

• Meaningfulprofessionalimpactthroughworkthatsupportsthequality,safety,andreliabilityoftechnologiesusedinhealthcare.

• Continuousimprovementculturethatencouragesinnovation,technicalgrowth,andtheadoptionofeffectivevalidationpractices.