The Engineer's Role in the Biopharmaceutical Supply Chain – Part 3

This article was originally published in the September-October 2017 issue of Pharmaceutical Engineering® magazine. Missed part one and two? Catch up now – The Engineer's Role in the Biopharmaceutical Supply Chain – Part 1 and The Engineer's Role in the Biopharmaceutical Supply Chain – Part 2.

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

Roundtable #2—Facility Engineers: Securing the Future of Biotechnology

New technologies are being introduced to our industry at an ever-increasing rate. How do we build new facilities and introduce new equipment to keep pace with today’s changing technology and expectations? Enter the facility engineer. Facility engineers have a solid understanding of current GMP regulations and advancements in technology; they also have the ability to work with other technical disciplines to understand an organization’s complete business needs.

Participating in this discussion:

  • Chris Dela Cruz, Validation Engineer, Commissioning Agents, Inc.
  • Tim Stark, Director of Operations for the Pacific Region, Commissioning Agents, Inc.

Can you tell us about your job?

DELA CRUZ: Commissioning, qualification, and validation, with a focus on greenfield projects and older facilities requiring equipment upgrades/retrofits. Building off my time as a validation engineer, in which I completed projects in quality control, plasma fractionation, albumin manufacturing, and oral solid dosage, I am able to bring new best practices, ideas, and approaches in problem solving.

STARK: My expertise is in aseptic bioprocessing and biotech facility design. I connect skilled individuals with client needs. I spend my days understanding and anticipating what customers need and finding engineers to fulfill those needs.

What emerging technologies and trends are interesting to you professionally?

DELA CRUZ: There is a push to digitalize the previously paper-intensive validation process as "execution on glass." Instead of taking hundreds or even thousands of pages to the field, this can all be done with a tablet. This is similar to how the industry has migrated from written batch records to electronic batch records.

STARK: Significant is the move from tradition, the somewhat duplicative process of commissioning and qualification to the ASTM E2500 verification standard.

What advice would you give to individuals interested in your area?

DELA CRUZ: Many are unsure about what area they want to work in. Working for a company that provides contract validation work will allow someone to experience a variety of roles.

STARK: Try to gain experience that will help you see different points of view, such as the difference between working in an R&D or manufacturing environment, or the difference between working for a manufacturer or service provider. The ability to help your customer requires different skills than does the ability to help your boss/team. I would also say that if you desire a breadth of experience and a chance to see the world, you should choose consulting.

By: John Balchunas, Chris Smith, and Lucas Vann

Register now for the 2017 ISPE Biopharmaceutical Manufacturing Conference to discuss the latest developments in the biopharmaceutical sector with key international thought leaders.

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.