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GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…
Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…
Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration
Expert has successfully developed and led a diversity of complex operations and projects in a variety of cultures and environments. These range from turnarounds and startups of flagship greenfield operations to cross functional teams in world-wide new product launches, and…
Cleanroom and Dryroom Design and Construction for Most Industries
Expert has extensive experience in designing, constructing, and installing cleanrooms, process systems, and tools for the Wafer Fab, Nanotechnology Research, Photovoltaic, Lithium Battery, and Biopharm Industries, including Class 1 and Aseptic Filling Suites. In addition to his cleanroom construction services…
Near Infrared Spectroscopy, Multivariate Analysis, Pharmaceutical Analysis, (GMP)
Expert is an internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods, including near-infrared and multivariate analysis. Nineteen years of industry experience with increasing responsibility and five years of policy…
Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions
Expert has 15 years’ work experience in the development of nucleic acid -based in vitro diagnostic (IVD) devices. He has both theoretical knowledge and hands-on experience, spanning the entire IVD pathway, which includes biomarker discovery, preclinical & clinical assay validation,…
Clean Rooms and Plastic ElectronicSemiconductor Process Design
Expert has been involved initially the operation of large semi-conductor clean rooms and subsequently the design and commissioning of clean rooms within the semi-conductor, university, plastic electronic and lithium ion areas of clean room build. Expert has undertaken due diligence…
QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing,…
OSHA Compliance, Safety Engineering, Accident Investigation (Workers\’ Comp, etc.) and Environmental Remediation/Investigations
Upon graduation from the U.S. Merchant Marine Academy Expert served time in the U.S. Navy as Engineering Officer aboard a destroyer and continued on active reserve status for eight (8) years. Subsequently he received a Master of Science degree in…
New Product Development, Lean, Six Sigma Blackbelt, Semiconductors/MEMS
Expert has had extensive process engineering experience with a variety of types of CVD reactors, including atmospheric, vacuum/thermal, and plasma enhanced. He has developed copper CVD precursors, developed low-stress/controlled stress dielectric films, and metal films. He wrote a book on…