Sr. Project Engineer at Outbound Technologies and Compliance Consultant
Indianapolis, Indiana Area
Sr. Project Engineer at Outbound Technologies and Compliance Consultant
Indianapolis, Indiana Area
(Privately Held; Industrial Automation industry)
April 2006 — April 2009 (3 years 1 month)
(Public Company; 5001-10,000 employees; Medical Devices industry)
January 2004 — April 2006 (2 years 4 months)
Provided validation guidance to develop updated and compliant validation program for specific sectors of the facility. Worked with multiple teams to develop and implement validation policies and procedures that included cleaning validation, process validation, CSV, equipment/utility validation, change control, and risk assessment.
(Privately Held; 11-50 employees; Pharmaceuticals industry)
2000 — 2006 (6 years)
Provided validation and compliance consulting services to various clients including Eli Lilly and Roche Diagnostics. Involved with projects ranging from 1K to 2M dollars.
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
October 2000 — January 2004 (3 years 4 months)
Provided validation services to client in multiple areas. Developed and executed IQ and OQ protocols for major capital project. Also developed full validation lifecycle documentation and was given responsibility for project management of multiple projects ranging from 5K to 300K.
1995 — 2000
ASQ Leadership, PMI, ISPE, JETT, APICS, Toastmasters, Smaller Indiana