Yen

Manufacturing Process Specialist Lead @Noramco

Philadelphia, PA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2015 — Present

Manufacturing Process Specialist Lead @Noramco

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Wilmington, DE, US

EDUCATION

2000 — 2005

Drexel University

Bachelor's Degree, Biomedical Engineering

2009 — 2010

UC San Diego

Professional Certificate in Quality Assurance and Control for the Drug and Biologic Industry

2005 — 2007

Drexel University

Master's Degree, Biomedical Engineering

SKILLS

FdaGmpQuality SystemAnalytical TechniquesProject PlanningSupply ChainCapaTechnology IntegrationRoot Cause AnalysisStrategic PlanningMicrosoft OfficeMaster Data ManagementLean Six SigmaData AnalysisEquipment QualificationMinitabProduct IntroductionLean ManufacturingTechnical LeadershipProject ManagementEmployee TrainingContinuous ImprovementValue Stream MappingValidationCleaning ValidationProcess ImprovementProcess CapabilityTechnical WritingTeamworkRisk ManagementCross-Functional Team LeadershipStatisticsEngineeringProcess EngineeringSapTechnical SupportTeam BuildingProduct SpecificationChange ManagementProcess Safety

ABOUT YEN

Engineering professional with demonstrated ability to implement controlled change and innovative improvements to deliver results. Diversified professional background with experience in quality, analytical, chemical engineering, project management, operations, and supervisory functions in GMP pharmaceutical manufacturing. Skilled with direct experience in: technical operations, validation, life cycle management, lean manufacturing, GMP compliance, statistical data analysis, chemical processing, risk and financial assessments, analytical testing, continued process verification, lean six-sigma black belt training, business impact evaluations, change management, and leading cross-functional project teams.

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