Experience

Genalyte, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Manufacturing Engineer

  • Sep 2013 - Present

  Responsible for instrument disposable array manufacturing. Supporting on-going manufacturing process, improvement implementation, scale-up of production and quality of final goods level increase and inspection. Management of row materials and vendors review. Responsible for instrument disposable array manufacturing. Supporting on-going manufacturing process, improvement implementation, scale-up of production and quality of final goods level increase and inspection. Management of row materials and vendors review.



Shire

• Japan
• Biotechnology Research
• 700 & Above Employee

• Plant Engineer II

  • 2011 - Present



Advanced BioHealing

• MFG Support Engineer II

  • Jul 2008 - Jul 2011

• MFG Support Engineer

  • Jul 2006 - Jul 2008

  Supporting on-going MFG need with exist/new equipmentSubmit Change Orders for Process/Product improvement in QA department.Conducting Investigation reports for non-conformance events.Execution of I/OQ runs for new/up-graded equipment or process change in Production.Designing new prototype of process equipment and approbation in ENG lab with following ENG study and validations.Creation of new Production batch records, SOP, calibration specification forms, equipment system specification, Drafting risk analyses and design review for MFG process changes.Proficient with AutoCAD and SolidWorks application: 2-D drawings in Autocad with layers customization, 3-D drawings and models creation in SolidWorks. Show less