Our Member Spotlight this month is Michelle M. Gonzalez, P.E., who retired in 2007 as an Engineering Director with Amgen Inc. Michelle’s extensive career includes leadership positions in facilities engineering, process systems design and management of construction projects with firms such as Shell Oil, Kaiser Engineers, Bechtel Corporation and Fluor Engineers. Since retiring, she has been involved with her own research projects and biopharmaceutical industry technical consulting.
As an active Member of ISPE for 23 years, Michelle has been heavily involved in the Society in a number of ways. In addition to being a regular technical speaker at ISPE events in the US and Europe, she served as President of the Greater Los Angeles Area Chapter, frequent contributor to Pharmaceutical Engineering magazine and co-author of several ISPE Guidance Documents.
Michelle remains a dedicated volunteer, who currently serves on the Knowledge Assets Committee; Pharmaceutical Engineering Committee and Reviewers; Annual Meeting Planning Team and the Steering Committee of the Critical Utilities Community of Practice (CU COP).
Q. Tell us a little about your career to date. How did you get started in the Life Sciences industry, and how has your career progressed?
A. My engineering career in the United States dates back to 1965 and it is clearly defined by two distinct periods; the one before biotechnology/pharmaceutical (1965-1987) and the most memorable and fulfilling, the one after 1987.
The first stage started when I was employed by Shell Oil, at their Martinez, California Refinery; after three years I moved to Bechtel Refinery and Chemical in San Francisco, California (69-76) with consecutive engineering stints at Kaiser Engineers in Oakland, California (76-79) and Fluor Mining and Metals, Inc. in San Mateo, California (79-83) where I was involved in projects dealing with the mining industry.
The second stage began when I returned to Bechtel National, Inc. in San Francisco, California (83-86) and subsequently, Fluor Daniel, Redwood City, California (86-87) where I had the good fortune to work in the world of “clean” facilities design for the manufacturing of microelectronics and the, then, very first biologic drug [EPO (Erythropoietin)] production facility in the world, designed and built for Amgen, Inc. in Thousand Oaks, California.
I did return to Bechtel National, Inc. (87-99) and Fluor Daniel (99-02), where I continued to be dedicated to the biopharmaceutical facilities engineering design, and construction quality. Finally, I concluded my “official” career by working at the same place where I started my most cherished professional period, Amgen, Inc. in Thousand Oaks, California.
Q. How did you get involved in ISPE, and what activities have you been involved in?
A. By the time my professional career began its second stage, it became quite clear that new challenges were looming and that I needed to be prepared to face them. Consequently, the change in focus for the continuous learning process required all my attention; as part of this process, I not only looked for sources of learning and/or expanding my basic abilities, but I made the commitment to take an active role in disseminating/sharing my existing education and my newly acquired knowledge. That is when I joined ISPE and other related technical organizations. In the beginning, my primary goal was learning as much as I could. But as I moved along, I became actively involved in a number of ISPE’s Committee functions, speaking at numerous meetings and writing articles for Pharmaceutical Engineering.
To this day, I continue to work with various ISPE organizational Committees and co-author some of ISPE’s educational publications such as the Biopharmaceutical Manufacturing Facilties Baseline® Guide (2004); Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems(2007); Second Edition of the Water and Steam Systems Baseline® Guide (2011); Good Practice Guide: Process Gases (2011); Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems (2012) and Good Practice Guide: Quality Laboratory Facilities (2012).
In March of this year I had the distinct honor of being the Keynote Speaker for the European ISPE Critical Utilities Conference in Copenhagen, Denmark, and as recently as last year, my latest technical article titled 'Rouge: the Intrinsic Phenomenon in 316L Stainless Steel’ was published in the ISPE Pharmaceutical Engineering July/August 2012 issue.
Q. What is your proudest accomplishment from your work with ISPE?
A. I believe that my proudest accomplishment as a volunteer for ISPE has been the research, preparation, editing and general maintenance of the Glossary of Applied Terminology for the Pharmaceutical Industry. This informative document traces its starting point to the early 80s, the time I became involved with the then nascent industry of Biotechnology; its inspiration was a document titled “The Language of Biotechnology” authored by Miss Ann C. King of the Phillips Petroleum Company Research Center. This document not only helped me to improve my knowledge of this exciting innovative technology, but also compelled me to create a source for sharing the educational value from which I had benefited.
At the end of 2003, I donated my work to ISPE, and with the invaluable help of Ms. Susan Humphreys Klein, ISPE’s past Executive Vice President, CFO, and Mr. Mel Crichton of Eli Lilly (Retired), the “Glossary,” as it is known, was introduced on the ISPE website; throughout the ensuing years this document has become the point of reference and/or collection for all the terms and acronyms utilized in all the ISPE published Guides and other general educational materials, as well as a gathering point for referencing terminology from worldwide regulatory organizations and biopharmaceutical concerns that have an impact in both the pharmaceutical and biotechnology industries.
Q. What advice would you have for those who would like to follow in your footsteps and become more involved in ISPE?
A. My most sincere advice may be contained in my personal thought that “no matter how old we are or will become, in the final analysis, we either do not know or will not know much/enough about anything, and that we still may have a lot to learn.” So, it is of cardinal importance to continuously expand our knowledge by our own experiences as well as by those shared experiences of others.
Once some level of knowledge has been acquired, it should not be kept within oneself in the mistaken belief that it will provide us “safety” in our employment or life status. It should be shared to make our societal standing firmer and more successful. When you have paired knowledge with the personal desire to contribute to the benefit of humankind, you will have achieved the almost perfect combination for personal satisfaction and professional success.
When joining an organization like ISPE, we should not only think of the benefits we may be entitled to receive from that membership, but rather, how we can also contribute to the improvement and betterment of the organizations that offer us the added opportunity to interact with professionals with similar interests, and the desire for expanding the technical knowledge in the industry that is dedicated to the well-being and health of our fellow human beings.