Clients – Patheon (Durham, NC) Metabolon (Durham, NC), Mallinckrodt (Hazelwood, MO), Bristol-Myers Squibb (New Brunswick, NJ), Biogen (Durham, NC), BD Medical (Sandy, UT), Confidential (Winston-Salem, NC)• Lead/manage retroactive validation effort for a custom LIMS (Metabolon)• Lead/manage validation effort for an enterprise LabVantage LIMS implementation at four sites; manage development/unit testing of LIMS application and custom components; act as Software Quality lead for Insight, JDE E1, NextDocs (Hosted and In-House), and Chromeleon upgrade (Mallinckrodt)• Configure LabWare LIMS assays, Empower and instrument interfaces, product specifications, and reports and lead/manage subsequent validation efforts; lead familiarization sessions with customers for LabWare assays and interfaces; administer system and handle associated IT tickets; lead/manage validation efforts for numerous analytical instrument/software projects (Biogen)• Manage all validation efforts within the company’s R&D unit, ensuring analytical instruments, equipment, processes, and computer systems properly perform their intended use; assist in the development of the company’s overall quality system and validation approach, including development of SOP’s (Confidential)• Lead/manage global validation efforts for Biovia Discoverant implementation and associated hierarchies (Patheon and Bristol-Myers Squibb)• Lead/manage validation efforts for SQL*LIMS common deliverables functionality and lot plan verification (BD Medical)