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Pfizer Inc. Thermal Packaging Engineer Manager EMEA in Denver, Colorado

The Thermal Packaging Engineering will be responsible for the following:Support the thermal qualification of controlled temperature shipping systemsfor Intercompany Operations and In-Market distributionMaintaining portfolio of new product launches (NPL) with Global LaunchOperations (GLO) with a focus on biologics and biosimilarsSupporting timely filing of MLA/BLA, and other MOH/BOH licensing andregulatory amendment applicationsEstablishing global strategies for selecting thermal packaging conveyancessupporting PIH and PCH New Product LaunchesEstablishing bracket methodologies and matrices for thermal conveyancequalifications as part global product registration and regulatory dossiersfilingsEstablish requirements for global thermal profiles per global MOH and BOHrequirements in support of qualification and thermal bracketing strategiesEnsure the execution of shake/drop and shock/vibe studies are executed perASTM standardsSupport thermal studies across the network to support Zero Defects StrategyResponsible for compiling data to be filed in the Qualification and Validationsection of Shipping Solutions in regulatory dossiers.Role has direct responsibility for Control Tower operational support of intransit incidents, and intervention. This includes nonstandard business hoursupport (e.g. weekends) as required.ROLE RESPONSIBILITIESNew Product Launch (NPL) Support:Oversee the deployment of controlled temperature shipping technologiesincluding the identification, selection, qualification and implementationof solutions to support Business and Operational unit requirementsWork with Bio Tx, Pharma Tx, Consumer Health and Animal Health teams toprovide controlled temperature shipping technology perspectives and supportfor new productsServe as the technical representative to support GTS for controlledtemperature logisticsAct as a key interface/SME for controlled temperature shipment technologiesbetween Business and Operational units for NPL'sResponsible for executing data models using global seasonality data for thedevelopment of temperature control solutionsLeverage controlled temperature shipping component supplier capabilities inthe initiation and evaluation of system development/improvementsEstablish strategy for the execution of IQ/OQ/PQ for new product launchesand regulatory amendmentsRole has direct responsibility for Control Tower operational support of intransit incidents, and intervention. This includes nonstandard business hoursupport (e.g. weekends) as required.Validation and qualification supportWhen required, will author operational, performance qualificationprotocols and reports.Responsible for drafting technical documentation supporting qualificationstrategies established by LSC launch or regional leadsEnsures logistics compliance with regional regulatory requirements whereaccountableGeneral Operations SupportReal time shipment intervention and ensuring follow up actions withtransportation suppliers are actioned against predefined playbooks andStandard Operating Procedures.Technical skillsMaster's degree in Thermal Engineering or related packaging preferred orBachelor's degree, 3+ years experiences in Pharmaceutical Logistics,Thermal Packaging Engineering, Transportation or Supply Chain management inan international environment with experiences on temperature controlled/coldchain logistics and Transport Qualification.In depth knowledge of a broad range of controlled temperature shippingcomponents, systems, monitoring equipment, best practices and governingregulationsIn depth understanding of the regulatory guidelines impacting the requirementsfor qualifying and utilizing temperature control shipping systemsUnderstand the concepts of product label claim and stability data and how toapply to the qualification processUnderstanding of processes used in development and qualification of controlledtemperature shipping systemsProven project management and complex problem solving skillsImpeccable technical writing skillsAbility to e

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