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Senior Validation Engineer

Company: Management Recruiters of Edison
Location: Lawrence
Posted on: January 20, 2023

Job Description:

Our client - a global company with multiple plants in the US, needs a Sr.Validation Engineer at a growing plant expanding to manufacture pharmaceutical products. Excellent salary + Annual Bonus + Generous allowancefor Relocation + Full Benefit Package + Client will sponsor for OPT or H1 Transfer Visa + Green Card if needed.



Job Posting # 2547



Job Title: Sr. Validation Engineer Location: Lawrence, KS



Compensation:Base salary of $90K - $110K per year + Annual Performance Bonus



Relocation: YES - Client offers relo assistance with a generous allowance



Benefits: Full package for medical, dental insurance, 401K, etc.





Our client is a privately held group of global companies in business for 40 years with 1,400 people. They have 4 major manufacturing sites in CA, TX, KY and KS



Group Info: Be part of the Medical device and Pharmaceutical contract manufacturing site with around 100+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing.



The new operation expansion is for Pharma Fill Finish Seal - FFS of Sterile Aseptic liquids.



This person will be part of the Plant Engineering Group and reportdirectlytotheSr. Directorof Engineering.



Job Summary:



The Validation Engineer coordinates andassistswithallprocess, equipmentchangesand implementation ofnewsystems,equipment,andproducttransfers.



TheValidationEngineerfacilitates ProcessDevelopment meetings,keepingtrackofvalidationprojectsandtheirstatus. TheValidation Engineerresearchesnewprocessesandsuggestsimprovementforcontinuedexcellenceandprovide assistanceon troubleshootingexistingprocessesand equipment.



TheValidation Engineerparticipatesin continuous improvement and KaizenprojectsinsupportoftheQualitySystem.



The validationengineerleadsanddrivesthe(ProcessPerformanceQualification) whichprovidescriticaldocumentedevidencethatamanufacturingprocess consistentlyproducesa productthat meetspredeterminedspecifications.



processvalidationapproachassessescriticalunit operationsateachstepoftheprocess,asgoverned byCriticalProcessParameters(CPP's)andCritical QualityAttributes(CQA's).



Job Description:



Thispositionrepresentsengineeringandvalidation fornewsystemsdesign,build,installationand commissioningaswellasequipmentalreadyinservice,byprovidingtechnicalinformation, writing,and reviewofURSdocuments.
Supportsengineering,QA andvalidationeffortsbyperforming(FAT)Factory Acceptance Testingand(SAT)(SiteAcceptancetesting),commissioningand allsitetesting/validation activities, thistoincludecalibrationactivitiesandsupport.
Writes andexecutesprotocolsforqualificationeventsinalignment withQA/QC.
Writes andrevisesprocedurestosupportnewsystemsor newproductrealization projects.
Maintainsprofessionalandtechnicalknowledgebyattending educational workshops andreviewingprofessional publications.



Applygeneralengineeringprinciplestodevelopandimplementcapitalprojectsthatwillreduce costs, improveoperatingefficiency,progress quality, andimprovesafety.
Providetechnicalexpertisetodefineapproachesandexecutionofsystemvalidationactivitiesin accordancewithcGMP,cGXP,CFR 21Parts,11,210&211,EUAnnex11,ICH Q7,Q8&Q9,and otherapplicable regulations, procedures,andindustryguidelines.
Provideengineeringsupportfornewequipment upgradesandspecialprojects.
Developprojectplansandschedules;estimatetimeandcosts; trackprojectprogression.
Participates indevelopments/ improvementstovalidationprogramsasneededtoremain current with cGMPs andindustrystandards.
Report onprojectprogress, limitingfactorsandissues, changesinprojectscope, develop contingencyplans, andresolveissuesimpedingprogress.
Collaborate withproductionpersonneltodevelopnew projects, identifylimitingfactorsin current projects, andcreate/maintainrelationships.
Participatesinteamsassembledtospecify,install,validate,troubleshoot,andmaintainsystems andequipment.
Providetechnicalsupportduring PreventiveMaintenance&Calibrationprogram.
Providetechnicalsupportfor spareparts procurement andinventorymanagement.
AssistProductDevelopmentwithengineeringsupportfor newproductlines.
Conductsvalidationdeviationsand/orparticipatesindeviationinvestigationstoidentifyroot causesanddefinecorrectiveand/or preventativeactions (CAPA).
Write,review,andexecuteprotocols.
AbilitytointerpretandrelateQualityandBestPracticeQualificationandValidationstandards for implementationandreview.
IQ/OQ/PQactivitiesfor facilities/utilities
Abilitytoworkindividuallyandwithinateam environment.



Candidate Must Have:

Bachelor's degree in Engineering or related field
Min. 5 year of Validation experience of facility, process, equipment, systems in BioPharma industry
Good people, communication skills to work in a team environment
Ability to produce and present clear, concise, and professionally written communications and presentations.

Candidate Nice to Have:

Master's degree in Engineering or Technical field
Experience in engineering, ISO execution, Quality Systems, commissioning, and qualification preferred and is used to determine job level (I-IV).
Knowledge of Sterile Aseptic Filling Operations
Startup or Small company experience working in a dynamic and hands-on role.
Contract Manufacturing experience working closely with customers and clients
Higher skill set with Performance ISPE or PDA classwork/training, Developing Standards, Process Improvement, Decision Making, Troubleshooting, Quality Management, Project coordination, P&ID reading, CAD or similar engineering software, commissioning and qualification principles, ISO Systems.

Keywords:BioPharma, Pharma, Quality, Validation Equipment, Process, systems, Sterile Aseptic filling, IQ, OQ, PQ, Protocols, H1 B visa, Opt Visa, Green Card sponsorship, CMO,CDMO.

Keywords: Management Recruiters of Edison, Lawrence , Senior Validation Engineer, Other , Lawrence, Kansas

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