Experience

PSC Software®

• United States
• Software Development
• 1 - 100 Employee

• Computer Systems Validation Engineer

  • Aug 2014 - Present

  I ensure current versions of ACE and subsequent versions of ACE (our proprietary Quality Managment System) and Audit Utopia (our Inspection Management System) are validated through verification and maintained in a validated state. I lead the validation effort and ensure validation timelines are met. My position requires that I have a solid understanding of industry standards, validation compliance requirements and supply support/technical knowledge for the development/refinement and implementation of validation standards. I also work with Senior Management, Development, Implementation, Quality, Business Development and Validation members to manage and create long-term strategy and systems, allocate resources to projects, manage timelines for projects, determine departmental budgets and develop the talent within the department. I currently host the site audits from clients for ACE/Audit Utopia and am responsible for validation audit responses. I represent the Validation function on cross-functional teams. Show less



PSC Biotech Corporation

• United States
• Biotechnology
• 300 - 400 Employee

• Software QA Engineer

  • Aug 2012 - Aug 2014

  CSV Engineer and responsible for generating test scripts for clients and assuring GXP compliance.

• Validation Intern

  • Jun 2012 - Sep 2012

  Developed and produced CGMP and GMP compliant validation documents.



PSC Biotech Corporation

• United States
• Biotechnology
• 300 - 400 Employee

• Validation associate

  • 2012 - 2012