Amy Toscano

Experience

1. Senior Process Engineer

   Takeda

   Aug 2024 — Present · Lexington, MA, US

   Engineering technical lead for upstream recovery and downstream purification operations including chromatography, ultrafiltration/diafiltration, viral inactivation, filtration (depth, viral) and drug substance bottling- Support and serve as SME on equipment and automation design for delivery of multiple biologic technology transfers (new product introduction) to commercial scale operations- Responsible for troubleshooting and root cause analysis of process equipment in commercial/clinical GMP manufacturing, providing on-call and on-floor support- Mentor junior staff members during troubleshooting and problem solving- Owner and technical SME for quality systems including deviations, CAPAs and change controls- Well versed in various software and systems including UNICORN, DeltaV, PI Historian, Trackwise, Bluebeam, Visio, COMOS, Maximo and Veeva- Collaborate on the development of standardized documentation including SOPs, MBRs and IOQs- Primary liaison between Manufacturing, Facilities, and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities- Advise and execute on-floor testing during FAT, SAT, CTPs and IOQs- Own design and testing documentation including User Requirement Specifications, Piping & Instrumentation Diagrams, Alarm Rationalizations, Disposable Component Flow Diagrams, Configuration and Functional Specifications, Commissioning Test Protocols- Support audits from regulatory agencies including response preparation and SME presentation- Identify and implement equipment and automation continuous improvements- Develop and execute engineering test protocols to support feasibility analysis and design evaluation- Verse in risk assessment methods and facilitation.

Education

• Worcester Polytechnic Institute

  Bachelor’s Degree, Chemical Engineering

  2014 — 2018

Skills

• Data Analysis
• Mathematics
• Laboratory
• Research
• Chemistry
• Microsoft Office
• Chemical Engineering
• Powerpoint
• Microsoft Word
• Leadership
• Public Speaking
• Event Planning
• Nanoparticles
• Nanotechnology
• Mathcad
• Microsoft Excel
• Teamwork
• Time Management
• Management
• Microsoft Powerpoint
• Uv/Vis Spectroscopy
• Engineering
• Science
• Materials Science
• Communication
• Matlab
• Aspen Plus
• Autocad
• Solidworks