Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Summary:
Support/Leadclientpackagingdevelopment projectsfrominitialdesigntoongoingcommercialproduction.
EssentialFunctions:
LeadtheProjectManagement forimplementationofprojectspecificpackagingequipment new market launches andserialization requirements where applicable.
WorkwithGlobalSerializationteamandoutsideVendorstocoordinatechangestoSerialization
systems.
Contributetothedevelopment ofRiskAssessmentsPackaging Engineering LineTrialprotocols/ reportsand Packaging Master Batch Records.
Participateinthedevelopmentofclientpackagingserializationrequirements.
SupportqualificationofERPsystemsrelatedtoserialization.
Supportcoordinationandexecutionofengineeringlinetrialsthatinvolvescomponentsscheduling training documentation serialization etc.
ManagecompletionofequipmentCorrectiveAction PreventativeActions(CAPAs).
Supportimplementationofimprovementsintobatchrecords.
Liaisewithfunctionalareas(includingclientsandvendors)tomeetprojectobjectives.
Participateincontinuousimprovementactivitiesasneeded.
Maintainasafeworkingenvironmentandreportpotentialhazards.
Performalternatingorrotatingshiftworkas.
QUALIFICATIONS
Education:
College/TechnicalSchooldiplomainrelevanttechnicalfield.
Experience:
Minimum3yearsofpreviousrelatedexperienceandgeneralknowledge ofadrugpackagingvalidationor packaging production.
Experienceinpackagingtechnical/scientificdiscussionswithclients.PreviousProject Managementexperiencean asset.
Equivalency:
Equivalentcombinationsofeducationtrainingandrelevantworkexperiencemaybeconsidered.
KnowledgeSkillsandAbilities:
General understanding of drug packaging processes and sterilization.Good Manufacturing Practices Standard Operating Procedures and Food and Drug Administration (FDA) compliance knowledge. Demonstrates organizational skills relevant to drug packaging.Strong technical writing and oral presentation skills.General knowledge of experimental design.General understanding of drug product validationandcommunication.Abilitytorecommendimprovements relatingto pharmaceuticalpackaging equipmentprocessesandsystems.Activelyacquiresnewskills/knowledgerelevanttothedrugpackaging process. Draws on experience anddemonstratesinnovative approach.Works autonomously under general direction to meet project and teamobjectives.Established quality regulatory and productionmentalityincludinganappreciationforclientserviceandthecontractmanufacturing industry.Demonstrated computerproficiencywithMicrosoft Officeprograms.ProficiencywiththeEnglishlanguage.
KnowledgeSkillsandAbilities:
Extensive knowledge and understanding of drug packaging processes as well asdrugproduct validation andcommercializationprocesses.Demonstrates organizationalskillsrelevant to drug packaging.Strong written and oral communication skills.Extensive knowledge and experience with experimental design. Detail oriented and organized with a high degree of accuracy andthoroughness.
Required Experience:
IC
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