Validation Expert: On the Cutting Edge

Stacy N. Hackett

It's an exciting time in the medical manufacturing industry, with numerous start-up companies sprouting and many biotechnological advancements on the verge of making their breakthroughs. These industry trends and the potential for growth are what attracted E. Ralph McKenzie, vice president of compliance operations for Oak Grove Technologies, Inc. (Mundelein, IL), to switch his career focus from manufacturing to validation.

McKenzie explains, "I knew the industry was going to be more regulated and decided this was the area to focus on. I hoped the switch was going to pay off, and it did."

McKenzie initially entered the manufacturing side of the medical device industry, where he spent seven years before switching to validation. Although McKenzie enjoyed the challenges of manufacturing, he recognized the changing regulatory climate and decided to make a move. Validation also appealed to McKenzie because it involves so many different areas, such as manufacturing, QA, inventory, and facility management.

E. Ralph McKenzie credits his ability to advance in the workplace to his flexibility, foresight, and willingness to learn.

"I wanted to be on the cutting edge of bringing new ideas to validation," explains McKenzie. "I want to use validation as a tool to help process improvements, not just churn out documents." One way to do this is to start the validation effort during the concept development stage.

McKenzie has served as director of pharmaceutical and biotechnology services at Sverdup Facilities, Inc. (Chicago), validation manager at Amersham (Arlington Heights, IL), and senior validation engineer/calibration supervisor at Schering-Plough (Des Plaines, IL). He recommends that people should strive for diverse experiences as they go down their career paths. "When I was with one company for 13 years, I was focused on one area," he explains. "Doing that, you don't have any growth potential other than going up the corporate ladder. At a big corporation, it's hard to make a move to another branch or division."

McKenzie says that he had no specific industry mentor. Rather, he acknowledges the multitude of people he worked for as being role models. "I got where I am today because I'd see someone doing what I wanted to do," McKenzie says. "I'd tell them where I wanted to be in 10 or 15 years and ask them what I needed to do to get there."

Being a mentor, however, comes naturally to McKenzie, although he doesn't participate in an official mentoring program. Recognizing that a college or technical school education provides the mind with tools but not practical experience, he explains, "We'll take young engineers and groom them and tutor them in certain areas and then cross-train them."

According to McKenzie, a current trend is for companies to outsource their validation, which makes his recent move to Oak Grove Technologies, a cGMP compliance consulting company, a fortuitous one. He is pleased with the move because, he says, in such an environment "your knowledge base just grows tremendously. You have to know a lot about everything to serve many types of clients."

McKenzie predicts that software validation will be one of the industry's hottest areas within the next 5 to 10 years. "I'm not even talking about the year 2000 thing," he says, "but automation and the elimination of jobs."

Luckily for him, computers are unable to usurp his role as mentor. "There's really no college for validation," says McKenzie. "It's all on-the-job training." He says that the switch to validation was definitely the turning point in his career. He credits his ability to sense the shift in the industry and his willingness to trust his intuition for his continued success, and he encourages others to create their own momentum. "What I'd tell a person interested in this industry is that validation is the field to get into, because it is doing nothing but growing."

Stacy N. Hackett is a freelance writer based in Huntington Beach, CA.