Julio has thirty seven years of experience. Twenty nine of these years have been in the pharmaceutical, medical devices and pharmaceutical primary container design and manufacturing sectors. This experience has included:
-Manufacturing and distribution of terminally sterilized and sterile filled parenteral products, both small volume and large volume parenterals.
-Support of manufacturing operations in Europe, Latin America and the Far East.
-Certification of facilities to ISO standards in anticipation of the CE mark approach.
-Design and manufacturing of Class I, II and III medical devices.
-Regulatory submissions for Class I, II and III medical devices in the US, CE mark of Class 1, IIa, IIb and III in Europe and registrations in Asia and Latin America
Most recently Julio had the opportunity to lead the establishment of an organization, quality system and infrastructure needed for the manufacturing of a novel primary package container for pharmaceuticals and biotech products. This experience afforded him the opportunity to:
-Work with the design, fabrication, qualification and validation of a 160,000 sq. ft. manufacturing facility that included three 13,000 sq. ft. Class 7 clean rooms.
-Develop and Implement inspection systems to assess the quality of nano scale coating systems.
-Develop a new approach to Container Closure Integrity testing of glass coated containers.
Currently residing in Auburn, Alabama.