Chip has broad experience with validation of facilities, utilities, and equipment; computer system validation; process validation; and cleaning validation. This experience includes manufacturing, packaging, and laboratory facilities; critical utilities; aseptic processes and sterile filling; oral solid dose manufacturing; packaging systems; environmental chambers; and warehouses. As a quality consultant, Chip has experience with quality systems, QRM, risk assessment, root cause analysis, change control, corrective and preventive actions, and failure investigation. Chip has managed facility qualification and cleaning validation projects for clients in the medical device and regulated nonpharmaceutical industries.
He has been an ISPE member since 2002 and is a sought-after speaker and author in the industry. Chip has presented multiple times at ISPE US Annual Meetings, ISPE Aseptic Conference, ISPE Shanghai conference, ISPE Boston Product Show, several local ISPE Chapters, PharmExpo, the Parenteral Drug Association Annual Meeting, and several Knowledge Exchange Network (KENX) conferences.
Chip was the lead author of the ISPE Good Practice Guide: Good Engineering Practice (Second Edition) (2021), a core contributor to ISPE Good Practice Guide: Validation 4.0 (2025), and an author or co-author on several Pharmaceutical Engineering® articles. Chip is a member of C&Q Community of Practice (CoP) steering committee; a member of the Radiopharmaceuticals CoP steering committee; an active author, presenter, and contributor in the ISPE Validation 4.0 Special Interest Group as part of the ISPE Pharma 4.0 working group; and an active member of the ISPE Great Lakes Chapter.
Chip has conducted training in the US, Europe, and Asia, and is an ISPE Qualified Instructor for G01 Fundamentals of GMP, T40 QRM-Based C&Q, and T75 Good Engineering Practice. He has a Bachelor of Science in chemical engineering from the Rose-Hulman Institute of Technology. Chip lives in Indiana with his wife and two daughters. In his free time, he enjoys spending time with his family and pets, escape rooms, karaoke, tennis, traveling, cruising, reading, cooking, coffee, wine, and cheering for the Indianapolis Colts.
I enjoy knowing that the work that I do, in whatever small way, contributes to safe, quality drug products reaching the patients who need them.
How Did Your Career Journey Unfold?
My career began in college, where I had a co-op with a systems integrator and gained my first experience with qualification. That experience led to my first job out of college, as a controls engineer. I quickly transitioned to a validation services provider role. From there, my career has spanned more than two decades, including roles with owner companies and as a services provider and consultant, supporting oral solid dosage manufacturing, aseptic manufacturing, contract development and manufacturing organizations, and radiopharmaceuticals manufacturing.
What Do You Enjoy Most About Your Work?
I enjoy knowing that the work that I do, in whatever small way, contributes to safe, quality drug products reaching the patients who need them—knowing that these patients, who often include family, friends, and colleagues, receive therapies that improve and even save their lives. Professionally, I love teaching—whether as a formal instructor, as a consultant to clients, or as a mentor to colleagues—and contributing to industry thought leadership and best practices.
What Is a Project You’re Proud Of?
One project in particular comes to mind: a facility expansion and tech transfer for an animal health facility. I managed the commissioning, qualification, and validation process and activities for the facility expansion, implementing and executing a risk-based approach that was novel for this particular site. Additionally, I developed and successfully managed the risk-based cleaning validation approach to support the tech transfer of 70 products to the site as part of the project.
What particularly stands out was helping drive cultural change for the site to implement the risk-based approach and watching the site validation lead not only learn, understand, and take ownership of the approach, but also successfully defend the approach and its outcome to regulators. Because the site manufactures aseptic animal health products, regulated by the US Department of Agriculture, the project presented a unique opportunity to demonstrate a science- and risk-based approach outside of conventional, US FDA-regulated facilities—and serves as a reminder that our patients are not always human. Our animal patients share their human patient counterparts’ expectations of drug products that are safe and effective.
What Do You Enjoy Most About Being a Member of ISPE?
I most enjoy the people—the ISPE membership. ISPE provides unparalleled networking, access to industry experts, and camaraderie. ISPE is open to all who want to participate, contribute, and lead. I have made lifelong colleagues, mentors, and friends through ISPE and hope that I give back in equal measure.
