Validation Consultant:

Richard J. Bognanno

** *** ****** ****, * – * (**7) 759 – 0325

Doylestown, PA 18901 acohw8@r.postjobfree.com

Experience

Covex LLC – Wayne, PA June 2012 – Present

Validation Consultant

• Work with pharmaceutical and biotechnology clients including Merck & Co., Horizon Scientific, and Sanofi U.S. to develop and execute solutions to complex laboratory and manufacturing needs.

• Lead and assisted projects consisting of the development of new processes and procedures for systems in use; system development and implementation for new laboratory equipment and processes.

• Professional skills include working on Corrective and Preventative Action Investigations (CAPA), Change/ Version Control Processes, System Development Life Cycle Documentation (SDLC), 21 CFR Part 11 Compliance, ISO 9000, Current Good Manufacturing Processes (cGMP), and Current Good Laboratory Processes (cGLP).

Merck & Co., Inc. – West Point, PA Feb 2013 – Present

Validation Specialist, Equipment Support Group April 2013 – Present

• Project lead for an ongoing CAPA investigation involving change/ version control policies and work flows from 2009 through 2014. Investigation is being resolved with corrective actions ensuring compliance on outstanding change/ version controls and establishing new work flows for future projects.

• Project lead for a CAPA instituting a new method of raw material testing due to the expiration of the previous license. Project details included installation, validation, performance qualification, and standard operating procedure implementation of a genetic analyzer and microbial and fungi

identification software.

• Project lead for a CAPA automating a manual raw material test of human cell lines. Managed the installation, qualification, and implementation of a new percentage match software resulting in faster and more accurate results.

• Executed over 50 change/ version controls to update, modify, or retire laboratory systems.

• Authored and executed necessary system life cycle documentation to ensure a new or modified system is within cGMP and remains compliant.

Validation Specialist, Vaccine Manufacturing Science & Commercialization Feb 2013 – April 2013

• Project lead for the installation and operational qualification of a dynamic light scatterer used to

verify the size of a virus used in a production environment. Authored and executed full system

development life cycle documentation.

Horizon Scientific, Inc. – Summerville, SC Dec 2012 – Jan 2013

Consultant, Manufacturing

• Performed the operational qualification of field force refrigerators and executed temperature

mapping validation on 350 refrigerators to be used for product storage by Sanofi drug

representatives.

Sanofi U.S. – Bridgewater, NJ June 2012 – Dec 2012

Consultant, Information Solutions

• Authored and executed an upgrade for an iPad application used by field service representatives

and health care providers.

• Reviewed change/ version control processes for eight GxP and non-GxP computer systems to determine the compliance state. Assisted with the remediation process on five systems deemed non-compliant.

Villanova University – Villanova, PA Aug 2010 – May 2012

Undergraduate Research Fellow, Inorganic Research Jan 2011 – May 2012

• Synthesized and characterized ruthenium bipyridal compounds. Studies included photovoltaic, electrochemical, nuclear magnetic resonance, and UV/Vis absorbance tests.

• Conducted spectroscopy studies characterizing synthesized ruthenium bipyridal compounds for one week at the University of North Carolina Chapel Hill.

Teacher Assistant, General Chemistry I Aug 2010 – Dec 2011

• Responsible for preparation of that week's lab for General Chemistry I and grading papers.

Publication

Dalton Transactions Aug 2012

• Supporting author of “Structural, electronic and acid/base properties of [Ru(bpy(OH)2)3]2+

(bpy(OH)2 = 4,4'-dihydroxy-2,2'-bipyridine).” Dalton Trans., 2012, 41, 125**-*****.

Education

Villanova University – Villanova, PA May 2012

Chemistry – American Chemical Society Bachelor of Science

• Minor in General Business, Villanova School of Business

• Cumulative GPA: 3.46

Accolades & Accomplishments

President of Gamma Sigma Epsilon – Chemistry Honor Society Mar 2010 – May 2012

Attended a national conference representing Villanova's chapter at Fayetteville State University.

• Volunteered to lead chemistry demonstrations in local hospitals and underprivileged elementary

• schools.

National Society of Collegiate Scholars April 2010 – May 2012

• Top 20% of graduating class

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