Experience

Valspec

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Validation Engineer

  • May 2014 - Present

  EBM Project • Provided support on generation, re-testing and resolution of deviations for Building 8 Electronic Batch Management (EBM) system and development of Requirement Traceability Matrix documents as part of the LAMP Project Team – newly constructed Building 8 for the production of Albumin and Hemofil DeltaV Project • Provided validation/qualification support developing and executing Emerson’s DeltaV commissioning and qualification protocols and Requirement Traceability Matrix… Show more EBM Project • Provided support on generation, re-testing and resolution of deviations for Building 8 Electronic Batch Management (EBM) system and development of Requirement Traceability Matrix documents as part of the LAMP Project Team – newly constructed Building 8 for the production of Albumin and Hemofil DeltaV Project • Provided validation/qualification support developing and executing Emerson’s DeltaV commissioning and qualification protocols and Requirement Traceability Matrix documents as part of the LAMP Project Team

• Senior Validation Engineer

  • May 2012 - May 2014

  DeltaV Project • Quality engineering support including pre-approval and post-approval of DeltaV commissioning and qualification protocols, including EMs, Phases, and Recipes. Syncade Project • Provided supported to the TechVal Department on the OCN MES Upgrade project. The Manufacturing Execution System (MES) consisted of a configurable and custom software solution, Emerson’s Syncade Smart Operations Management Suite, which provides automated support functions for manufacturing… Show more DeltaV Project • Quality engineering support including pre-approval and post-approval of DeltaV commissioning and qualification protocols, including EMs, Phases, and Recipes. Syncade Project • Provided supported to the TechVal Department on the OCN MES Upgrade project. The Manufacturing Execution System (MES) consisted of a configurable and custom software solution, Emerson’s Syncade Smart Operations Management Suite, which provides automated support functions for manufacturing and quality operations. It supports paperless manufacturing, electronic batch records, point of use verification and integration with other operations support systems such as DCS, ERP and LIMS. • Responsibilities included but not limited to: review of Functional Specifications, Detail Design Specifications and User Requirements Specification documents to ensure testability and traceability. • Development and execution of Commissioning, Operational Qualification, Installation Qualification and Process Validation documents. • Review and update of Requirement Trace Matrix documents to ensure traceability between URS, FS, DDS and qualification documents.



Echo Consulting Group

• Amgen - Juncos, Puerto Rico

• Senior Validation Engineer

  • Apr 2010 - May 2012

  • Participated as a member of AML JU001 Manufacturing Facility Validation Team to provide validation/qualification support in several projects in the Packaging and Manufacturing Areas including: Kaye Digistrip 4 upgrade to the autoclaves PLC Recorder system of the Component Prep Area, Tank Wash, Formulation and Vials Rooms. This upgrade included the installation of a system composed of an Allen Bradley CompactLogix PLC and PanelView Plus for monitoring and collection of process data including… Show more • Participated as a member of AML JU001 Manufacturing Facility Validation Team to provide validation/qualification support in several projects in the Packaging and Manufacturing Areas including: Kaye Digistrip 4 upgrade to the autoclaves PLC Recorder system of the Component Prep Area, Tank Wash, Formulation and Vials Rooms. This upgrade included the installation of a system composed of an Allen Bradley CompactLogix PLC and PanelView Plus for monitoring and collection of process data including temperature, pressure and critical alarms. Other equipment included Kayence Ionizer Upgrade to Dividella Labeler machine, Nikon Automated Vision System, Instron Pull Tester, Eisai CIM (Cosmetic Inspection Machine) and AIM (Automatic Inspection Machine), Cognex Vision Systems, FarXE Overwrapper Machine, Marchesini Cartoner, Domino Laser Printer and Accraply Vial Labeler. • Participated in AML JU006 Nesp Re-introduction MP Re-design project updating/re-designing existing MP to new format as per requirements. Show less • Participated as a member of AML JU001 Manufacturing Facility Validation Team to provide validation/qualification support in several projects in the Packaging and Manufacturing Areas including: Kaye Digistrip 4 upgrade to the autoclaves PLC Recorder system of the Component Prep Area, Tank Wash, Formulation and Vials Rooms. This upgrade included the installation of a system composed of an Allen Bradley CompactLogix PLC and PanelView Plus for monitoring and collection of process data including… Show more • Participated as a member of AML JU001 Manufacturing Facility Validation Team to provide validation/qualification support in several projects in the Packaging and Manufacturing Areas including: Kaye Digistrip 4 upgrade to the autoclaves PLC Recorder system of the Component Prep Area, Tank Wash, Formulation and Vials Rooms. This upgrade included the installation of a system composed of an Allen Bradley CompactLogix PLC and PanelView Plus for monitoring and collection of process data including temperature, pressure and critical alarms. Other equipment included Kayence Ionizer Upgrade to Dividella Labeler machine, Nikon Automated Vision System, Instron Pull Tester, Eisai CIM (Cosmetic Inspection Machine) and AIM (Automatic Inspection Machine), Cognex Vision Systems, FarXE Overwrapper Machine, Marchesini Cartoner, Domino Laser Printer and Accraply Vial Labeler. • Participated in AML JU006 Nesp Re-introduction MP Re-design project updating/re-designing existing MP to new format as per requirements. Show less



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Validation Engineer

  • Jun 2009 - May 2012



Validation and Engineering Group

• Validation Engineer

  • 2009 - 2010



SmartER

• Commissioning Engineer

  • 2006 - 2007



Pharma Serv

• Validation/Quality Engineer

  • 2001 - 2006



Day & Zimmermann

• United States
• Construction
• 700 & Above Employee

• Validation/Commissioning/Quality Engineer

  • 2001 - 2003