Over twenty years of experience professional, founder and managing partner since 2010, of BioPharma Consulting Services, (BCS). Under his management BCS has been able to accomplish alliance contracts with companies in Japan and North America; while maintaining consistent sales growth by following strategically developed plans.Seasoned professional in chemical, pharmaceutical and bio-pharmaceutical industries in the area of Technical Services and Project Management. Knowledge of GMP’s and FDA regulations for manufacturing processes of Medical Devices and Solution drugs. Experience has afforded exposure on validation areas such as Visual Inspection (manual, auto, semi-automated) processes, Facilities, Utilities, HVAC, Process Equipment, Cleaning, and Computer validation system lifecycle and on the different stages of validation and management, including troubleshooting, start-up, commissioning, problem and discrepancies solving and performance improvement projects. Has occupied leadership positions on a highly regulated environment such as a Consent Decree at Schering-Plough, LLC Manati, PR operations. Manati Site went from extensive FDA 483 observations in 2000 to become the First FDA compliant Schering-Plough site under the Consent Decree by June 2006.Specialties: Visual Inspection Processes, Critical utilities, process equipments, temperature mapping studies, FMEA's, project management, remediation projects, strategic management