The Engineer's Role in Biopharmaceutical Supply Chain - Part 4

This article was originally published in the September–October 2017 issue of Pharmaceutical Engineering® magazine. Catch up now if you missed Part 1, Part 2, or Part 3.

To shed light on the role of engineers in biopharmaceutical manufacturing, this article presents three "virtual round tables" featuring engineers that work in each of these positions.

Round Table #3—Automation Engineers: Bringing Automated Control Systems to Production

Current automation and control systems to produce biologics and pharmaceuticals are well behind those found in other highly automated industries, such as semiconductor manufacturing. Routine monitoring and proportional integral derivative (PID) controllers do not provide control of many important critical parameters that impact critical quality attributes. Establishing a robust control strategy during process development that can be scaled up and transferred to manufacturing is crucial to ensuring quality throughout the product life cycle. While advanced monitoring tools are available, utilizing them effectively is challenging since advanced control solutions must be capable of predicting what might occur within a batch or unit operation and act accordingly to correct it. To meet current demands as well as be positioned to anticipate and overcome future challenges in automation, engineers must be equipped with the necessary skill set.

The following questions were posed to three engineers with various jobs and backgrounds. Each of these engineering roles, while different, are required to drive a complete automation control solution.

Participating in this discussion:

  • Saly Romero, Senior Manager at Biogen in manufacturing sciences; has extensive experience in data analytics and modeling
  • Thomas Jacobsen, Automation Engineer at NNE; works as a team leader for the company’s automation infrastructure
  • Amos Dor, CTO of the Automation Product Group at Applied Materials; works to provide enterprise solutions for both the semiconductor and pharmaceutical industries

Can you tell us about your job?

ROMERO: I lead a small team of data analysts performing data-driven modeling in the areas of process performance as well as advanced sensor calibrations. Based on my experience, I bring a strong skill set in data analytics, including real-time analysis and modeling, related to characterization and optimization with the overall goal of generating process intelligence, knowledge, and control.

JACOBSEN: I work in automation for pharmaceutical and biopharmaceutical companies, where I help to provide infrastructure for plant-wide turnkey installations including building management system, distributed control system, and supervisory control, and data acquisition systems.

DOR: I evaluate current technology platforms for both the semiconductor and pharma industries and work to promote new technologies and markets. I’ve managed to combine my software engineering education with entrepreneurial business and management skills to add a unique perspective in both a large company and start-up settings.

What has your career trajectory been like?

ROMERO: While pursuing my bachelor’s in chemistry at Purdue University, I had the opportunity to work for a university research center and developed calibration models for near-infrared as well as Raman applications, which was my introduction into chemometrics and data analytics. I then went on to work for a number of large pharma companies supporting both small- and large-molecule manufacturing by modeling for advanced sensor strategies as well as building multivariate analysis models to troubleshoot, identify process characteristics, and help with investigations. My experience enabled me to start my own consulting company, which led me to the job I have now.

JACOBSEN: As an undergraduate, I had the opportunity to work in a fermentation lab, where I began doing PID tuning and other automation and control activities on bioreactors. When I graduated, I began working for Novartis in statistical analysis but always wanted to do more in automation. I went back to school and earned a master’s from the Biomanufacturing Training and Education Center at North Carolina State University, completing an automation-centered project that led to my current job.

What emerging technologies and future trends are interesting to you professionally?

ROMERO: I see biopharma becoming less technology-conservative and more open to adopting advanced manufacturing technologies. It is a different way of thinking, as well as working, when compared to the classic approach in that it is knowledge-based rather than only skill-based.

JACOBSEN: Automation is a very expansive area in manufacturing and requires so many segments. This creates silos of dependencies in those areas, such as equipment programmable logic controllers (PLCs), user human-machine interfaces, and computer servers, to name a few. The future of automation must be one where these are integrated in a more seamless manner. This also includes security, which I feel is a specific area to focus on for the future as more systems become networked and more virtual-based systems are used.

DOR: The emerging trend of enterprise software solutions and machine learning to provide enhanced process understanding and prediction capabilities. Also, Industry 4.0 concepts of cloud-based integration and connectivity to enable mobile data collection and aggregation. I also envision more connectivity between the supply chain and more end-to-end integration for advanced decision-making. Eventually, I see the industry becoming like the semiconductor industry in that it will be more "lights off," meaning automation practices have been implemented to the point that the facilities can run themselves without significant human presence.

What is your proudest professional accomplishment?

ROMERO: I would say I am proud of my overall career path. I went from a bachelor’s in chemistry to becoming an advanced manufacturing expert. I am proud that I have had, and continue to have, the strength and desire to be able to keep up with this dynamically evolving area of the industry, and that throughout this process I have developed a strong network that appreciates my background and trusts me and my skills.

JACOBSEN: I am one of the youngest managers at NNE and I believe one of the reasons for this is how I have been able to learn and expand to keep up with how fast automation is growing.

DOR: Building a great network of people that has enabled me to grow professionally as well as build amazing teams of individuals. I am also very proud of being part of a start-up team that began and grew a multimillion-dollar company.

What advice would you give someone interested in automation engineering?

ROMERO: Never lose perspective of the physical world or process where the model will be applied. Any type of modeling or automation will require math skills, but the more knowledge one has of the process, the better one will be at performing their job duties.

JACOBSEN: Students fresh from university don’t seem to have a good grasp of input/output (I/O) and how controls work from the ground up. Programming PLCs is one thing but actually making the correct connections, programming the I/O points, and tying everything together to make a control system function as a whole is something that would be a great benefit.

DOR: I feel there are two main types of individuals: those who are extremely focused in one area and whom I would advise to make sure they are doing what they love, and those who are more holistic in nature and like to know about multiple areas, whom I would advise to always continue seeking to learn new things to be able to improve their overall capability to increase productivity.

What do you wish you had been able to learn as an undergrad?

ROMERO: More practical hands-on training. I learned a lot of math and theory but very little in terms of practical application.

JACOBSEN: I also feel there was not enough practical training in my undergrad degree. Learning how the equipment actually functions from the standpoint of understanding where the numbers on a control screen are coming from would go a long way. More focus on that helps an engineer to question data and not just blindly trust numbers that are being displayed

DOR: I would answer this more from the perspective of what skill set I feel is missing from recent graduates when they are looking for employment. I am always looking for good chemometricians, and there are very few students in the United States learning these skills in a practical way. Data is key, so the skill set required to make use of data that is being generated is crucial.

By: John Balchunas, Chris Smith, and Lucas Vann

Read the rest of the September-October issue Special Report on Biotechnology.

About the Authors

John Balchunas is Assistant Director, Professional Development Programs, at North Carolina State University’s Biomanufacturing Training and Education Center (BTEC), where he has responsibility for program management, business development, and partnership. Balchunas previously served as the director of workforce development for the North Carolina Biotechnology Center, an internationally recognized nonprofit corporation charged with creating jobs through support of research, education, and business. In an earlier career, John worked as a technical writer in the biotechnology and medical diagnostic industries. John holds a master of science degree in technical communication and a bachelor of science degree in microbiology from North Carolina State University.

Chris Smith, an ISPE member since 2014, serves as Graduate Programs Coordinator and Instructor of two graduate-level courses at North Carolina State University’s Biomanufacturing Training and Education Center (BTEC). He has been involved with developing BTEC’s academic programs and increasing industry ties since joining BTEC in 2011. Smith holds a master of science degree in molecular physiology and an MBA in marketing; he currently serves as the NCSU Student Chapter ISPE Faculty Advisor.

Lucas Vann manages the automation and engineering group at North Carolina State University’s Biomanufacturing Training and Education Center (BTEC). He has over 15 years of experience in upstream process development, scale-up and automation. He is founder of Biozaivan LLC, a consulting company specializing in advanced automation, process development, data analytics, and predictive maintenance and control. Vann leads the process analytical technology initiative at BTEC and is currently completing his PhD (ABD) in bioprocessing at North Carolina State University. He holds bachelor’s and master’s degrees in biosystems engineering from McGill University in Montreal, Canada.