Experience

Sagax Team

• United States
• Software Development
• 1 - 100 Employee

• Sr Validation Consultant

  • Apr 2021 - Present



Aerotek

• United States
• Staffing and Recruiting
• 700 & Above Employee

• Sr. Consultant, Analytical Services - Aerotek

  • Jan 2020 - Apr 2021

• Quality Engineer III

  • Nov 2017 - Jan 2020



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Project Manager at Merck

  • Aug 2018 - Jan 2020



CSols Inc.

• United States
• IT Services and IT Consulting
• 1 - 100 Employee

• Validation Consultant

  • Sep 2013 - Nov 2017

  Validation of Analytical Instrumentation following GAMP 5 guidelines. Development of ELN E-Workbook application for a QC environment. LabWare LIMS V6/Empower 3/NuGenesis 8 (SDMS) support for PDM organization. Validation of Molecular Devices SoftMax Pro GxP & GxP Admin software.Trackwise user for change controls, deviation management and CAPAs including effectiveness checks.Empower 3 Report Method Validation.



Hospira

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Validation Engineer

  • Nov 2011 - Aug 2013

• Validation Specialist

  • Jun 2011 - Nov 2011



Sequence Inc.

• Validation Consultant

  • Mar 2010 - Apr 2011

  Installed and validated a Waters Empower II FR5 instance for a development lab in RTP, NC. Qualified various analytical instrumentation for microbiological and chemical quality groups.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Scientist

  • Mar 2007 - Mar 2010

• Scientist I/Analytical Development

  • Jun 2004 - Mar 2007

  Duties/Responsibilities:Support the Vaccine R&D group through routine GMP testing in the support of CTM testing. These materials include 13V, MNB2086, ACC-001/ACC-002, GAS, and STAPH A.Testing includes use of all wet chemistry assays (Anthrone, Lowry, Modified Lowry, Uronic, Free Sugar, all aldehyde assays, Kd, etc) in addition to chromatographic assays (Free CRM, % DMSO, RC-529, Poly 80, capillary electrophoresis, instrumental cyanide, etc)Created and validated Excel spreadsheets for data calculations in support of GMP CTM production.Provided technical and scientific expertise in protein/carbohydrate chemistry.Ordered/Prepared reagents, standards, and controls for use in testing.Created and revised standard operating procedures.Participated in various validations and method transfers to the quality unit.

• Sr. Lab Assistant

  • Feb 2003 - Jun 2004



Lockheed Martin Corp

• Software Engineering Intern

  • Jun 1998 - Aug 1999

  Performed multiple MS Word to HMTL conversions for web SOP uploading. Various other IT support and administrative duties.