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Structural Engineer
Expert has over 42 years of experience and has served as a Project Engineer, Project Manager, Structural Department Head and Engineer of Record on a wide variety of commercial, institutional, manufacturing, process and industrial facilities throughout the United States and…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Formulation
Pharmaceutical product development, scale-up, commercial manufacturing. Process design, improvements, economic changes. Complex product development, bioavailability, absorption enhancement. Intellectual property analysis and guidelines for alternative strategies. Sourcing, quality, regulatory CMC guidance. Proven track record of 30 years in effective product development…
Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt
Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…
Equipment Validation
Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment. EQUIPMENT EXPERIENCE Ackley Imprinter Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves. Korsch - XL400WIP,…
Chemical Industry, Aluminum Sulfate, Polyaluminum Chloride
Expert is an Egyptian chemical consultant engineer in process design and chemicals plants developments for more than 45 years. Expert is currently Technical consultant to facilitate the group, Sheikh Industry sulfuric acid and poly-aluminum chloride and potassium sulfate and was…
Electrical Engineer – Design/Operation/Maintenance of Electrical Power Systems – Industrial/Utility
• Engineering Expert in Electric Power Systems & Energy for Utility, Industrial, & Facilities • Licensed Professional Engineer (Virginia & Florida) / Electrical Engineer • United States Citizen (Born in USA) • 36 Years Experience / Seasoned Professional / Qualified…
Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.
. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Pharmaceutics
Expert is a process and chemical engineer with a Bachelor from Univercity Laval in Quebec City. He has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems (cGMP, GAMP5, CFR-21…