Validation Engineer

PE Global (UK); Carlow; On-site; EUR 70,000 - 90,000; Full time

Job summary

PEGlobal is currently recruiting a Validation Engineer for a leading multinational Pharma client based in Carlow, Ireland. This contract position offers an exciting opportunity to contribute to cGMP compliant validation activities.

The successful candidate will design, execute, and review qualification activities, including sterilisation processes and SIP of vessels, and collaborate with Production, Maintenance and Quality teams to ensure compliant operations.

Qualifications

• Relevant technical qualification in applied pharmaceutical/biological/chemical sciences or applied technical/engineering qualification.
• Knowledge of CTU equipment qualification.
• Knowledge of thermal mapping equipment.
• Thermal mapping skills.

Responsibilities

• Design, author, review, approve, and execute validation documentation and cycle development studies.
• Design, author, review, approve, execute change controls.
• Resolve technical issues during study execution.
• Engage with Production, Maintenance and Quality during cycle development and PQ activities.
• Provide technical input into investigations and quality notifications.

Skills

Root cause analysis

Deviation management

Change control

Data analysis

Quality systems

Education

Applied pharma/biological/chemical sciences degree

Tools

DeltaV

Pi System

Job description

PEGlobaliscurrentlyrecruitingforaValidationEngineerforaleadingmulti-nationalPharmaclientbasedinCarlow.

Thisisacontractposition.

Role:

MyclientisexcitedtoofferafantasticEngineeringSpecialist(Validation)opportunityforcandidatesinterestedinanewchallengeinacGMPregulatoryenvironment.ThesuccessfulcandidateswillsupportseveralaspectsofValidation.Therolesavailablethatwillrequireexperienced,energeticandcommittedengineersinSterilisation–Autoclaves,SIPofvessels.

Responsibilities:

• Design/Author/Review/Approve/Executequalification/validationdocumentationandcycledevelopmentstudiesinlinewiththestandardapprovalprocess.
• Design/Author/Review/Approve/ExecuteExecution/developmentofchangecontrols.
• Resolvingtechnicalissuesencounteredduringstudyexecution.
• EngagementwithProduction,MaintenanceandQualityrepresentativesintheassignedareaofoperationsduringexecutionofCycleDevelopment&PerformanceQualificationactivities.
• Technicalinputintoqualitynotificationbyauthoring/reviewing/approvinginvestigations.
• Performrootcauseanalysisofsystemfailures,substandardperformance,usingstandardtoolsandmethods,toresolvemachineandsystemissues.
• SupportcontinuousimprovementthroughLeanSixSigmamethodologies.
• Serveasvalidationrepresentativeforcrossfunctionalprojectsandrepresentthevalidationteamatglobaltechnicalforums.
• DrivecomplianceofGlobalPolicies,ProceduresandGuidelines,regulatoryrequirementsandexecutecurrentGoodmanufacturingPractices(cGMP)intheperformanceofday-to-dayactivitiesandallapplicablejobfunctions,ensuringconsiderationoftheimpactonGMPandcomplianceanddecisionsmade.
• Accountableforcomplianceviadocumentationcompletion,riskassessments,closingoutcorrectiveactions,participationinauditsandinspectionsandproactivelyhighlightinganyissuesaroundcompliance.
• Supportingregulatoryauditsandsubmissionsasrequired.
• WorkcollaborativelytodriveasafeandcompliantcultureinCarlow.

Requirements:

• Relevanttechnicalqualification(s)inAppliedPharmaceutical/Biological/ChemicalsciencesorappliedTechnical/Engineeringqualification,thesuccessfulcandidatewillalsohaveaproventrackrecordindeliveringexcellence.
• KnowledgeofCTUequipmentqualification.
• Knowledgeofthermalmappingequipment.
• Thermalmappingskills.
• Exception/DeviationManagementandChangeControl.
• Demonstratableexperienceofleadingtechnicalrelatedprojects.
• Knowledgeofprocessmonitoringsystems,automationsystems(DeltaV),operationalintelligence&datasystems(PiSystem)withinaGMPmanufacturingenvironmentwouldbebeneficialanddesirable.
• Evidenceofcontinuousprofessionaldevelopmentisdesirable.
• Knowledgeofregulatory/coderequirementstoIrish,EuropeanandInternationalCodes,StandardsandPractices.
• Abilitytoanalyseandinterpretcomplexdata,andlinktoequipmentperformanceandoutofspecificationfindingsasappropriate.
• Report,standards,policywritingskillsrequired.
• Equipmentandprocessvalidation.
• SterileFill-Finishprocessesandequipment.

Interestedcandidatesshouldsubmitanupdated

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.