Senior Validation Engineer
Company: Management Recruiters of Edison
Location: Lawrence
Posted on: January 20, 2023
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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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here to apply!
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