John Patterson, M.S.E

Senior Consultant

John has recently joined the QACV Consulting team with over 30 years of bio-pharmaceutical experience in several different roles including engineering, technical operations, manufacturing, quality assurance and information technology.  Mr. Patterson possesses current skills in the development and deployment of quality management systems, risk management frameworks, quality auditing & governance and computerized systems validation including infrastructure qualification (including Cloud IAAS), application (MES) validation and GxP data integrity assurance. 
 
John also possesses significant experience preparing, managing and responding to IT & automation topics during GMP & GCP regulatory inspections. Mr. Patterson has also been involved with bringing cybersecurity to GxP systems and has been responsible for establishing an information security and data protection capability in his most recent role.   John keeps his skills current through regular speaking engagements at industry conferences, active involvement with multiple ISPE and industry SIGs and authoring/co-authoring of technical articles in leading industry publications including topics such as MES Validation (Institute of Validation Technology – IVT), Risk Management (ISPE Baseline Guide, Oral Solid Dosage Forms) and Bringing Cybersecurity to GxP Systems (Pharmaceutical Engineering Magazine).   John has a M.S. in Engineering from Purdue University and a B.S. in Agricultural Engineering from the University of Wisconsin-Madison.