SUMMARY
Experienced and innovative manager, process engineer, scientist, and technical leader specialized in industrial process, quality and sterilization. My experience includes from product/process development, validation and troubleshooting to applied research, and the improvement of industrial processes including commercial and terminal sterilization of food products, drugs and medical devices.
Demonstrated strong entrepreneurial, managerial and technical skills and the ability to establish strategically important customer relationships and utilize technical skills efficiently to achieve agreed objectives.
KEYWORDS
Sterilization, quality, process, engineering, management, process improvement, GDP, GMP, GLP, SQF, HACCP, terminal, commercial sterilization, steam, canning, ethylene oxide, radiation, optimization, innovation, communication, process authority, flexible and semi-rigid packagin.
RELEVANCE
Strong contributions concerning development and implementation of new products and processes, development and trouble-shooting of industrial processes. Integration of different fields of knowledge such as process engineering, quality, microbiology, biochemistry, food technology, etc. to generate efficient responses to relevant technical and regulatory issues.
Communication skills that enable efficient communication of complex information to pertinent stakeholders, and successful regulatory submissions (i.e. filed process filings for the CFSAN of the FDA)
CAREER HIGHLIGHTS
• Work for the pharmaceutical industry was related to sterilization process improvement, development validation and troubleshooting of industrial processes and products. Emphasis was on steam end ethylene oxide sterilization. Process and quality engineering tools were used to confine risk and improve significantly the efficiency of industrial sterilization processes. Significant savings and risk-reduction were achieved.
Several of the procedures used at xxx to develop steam and ethylene oxide sterilization cycles, and to validate sterilization cycles were developed. In addition the engineering characterization of the effect of the sterilization cycle on flexible packaging, and the characterization of the sensitivity of the tests used to validate the integrity of our products during their shelf-life were resolved to the satisfaction of regulatory authorities.
Work at xxxx involved validation of terminal sterilization of devices through the use of external laboratories and coproducers; and sterility assurance support of product development work.
• Development of the process engineering group at xxx in less than two years to the point that more than $1,000,000 of contract project work was finished.
• Work at xxxx involved sterility assurance and regulatory affairs work related to acidified and low-acid canned foods in flexible and semi-rigid packages using steam (water spray), and hot-air as lethal agents. Experience includes hot-fill-seal-hold, and sealed products.
EXPERIENCE
More than 20 years of professional experience as a process, sterilization and quality engineer. Work is mostly related to sterilization using diverse technologies such as steam (moist-heat), gas (ethylene oxide), radiation, ultra-high pressure, etc. The approach developed makes extensive use of quality engineering and process engineering advanced techniques.
Sr. Consultant, xxx. A consulting company dedicated to process, quality and sterilization technologies.
Consulting on modernization and improvement of industrial quality systems and on “due diligence” preliminary to a potential acquisition. GDP, GMP, GLP, SQF, HACCP.
Sr. Scientist, xxx. Process authority responsible for sterilization process development, validation and regulatory filing for acidified and low acid canned foods (work included temperature distribution and heat penetration tests). In addition, responsible for the process improvement corresponding to the “retort closed door” stages of the sterilization processes with ...
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