Edward Stevens Email & Phone Number

Over thirty years’ experience in bio-pharmaceutical Project Management , Process and Project Engineering, System integration and Automation, Process Instrumentation and Control Systems design, development and troubleshooting within a cGMP environment.As an Engineering Group Manager managed and directed all financial, human resources, training, technical, and communication aspects of the engineering and project management group. Delivered capital project budgets in excess of 30 million dollars that included upgrades and modernization of processes, process support equipment and functions, facilities, and automation. Lead multi-disciplinary project teams in a Biopharmaceutical development and clinical manufacturing facility. Served as a key liaison to Clinical Manufacturing User Groups, Validation /QA/QC, Process Development and Technical Transfer, Maintenance and Metrology, Facility Engineering groups. Implemented integration of new process platforms into the clinical process manufacturing.• Single Use Equipment technologies in mammalian cell culture and downstream purification• Microbial/Pichia/Saccharomyses fermentation platforms• Monoclonal Antibody - Chemical API or Radio isotope conjugation• Continuous perfusion and ATF process system in mammalian cell cultureDeveloped a strong knowledge of cGMPs, current industry standards, new technological process platforms, commissioning, qualification and process/cleaning validation execution methodology, and equipment operating procedures. Working experience with instrument calibration, work order systems, Preventive and Predictive Maintenance, CAPA implementation. Experience with engineering, integration and implementation of bio-pharmaceutical upstream and downstream process equipment/systems, Clean Utilities, CIP/SIP, BIo-waste handling and Inactivation, Buffer and Media management. Strong knowledge of Single Use and Aseptic Processing technologies

Listed skills include Validation, Pharmaceutical Industry, Gmp, Fda, and 14 others.