It’s about the process, not the destination

Stephanie Brandford's ('92) affinity for math and science, along with a serendipitous run-in with a high school guidance counselor, set her on a path to pursue chemical engineering as an undergraduate at Carnegie Mellon University. After four years, she earned her degree with an added concentration in computer-aided design and entered the field at Air Products and Chemicals, Inc., a chemical company specializing in industrial gasses and equipment. At one of their polymer manufacturing facilities, she started improving processes using statistics and maintaining compliance records for Environmental Protection Agency requirements.

Eventually, Brandford transitioned to the medical device field at Cambrex and was introduced to validation. Upon joining Becton Dickinson, she sought to delve deeper into optimization and compliance. Equipped with a Six Sigma Black Belt certification, she was responsible for using a whole host of statistical and analytical tools to help ensure the medical device manufacturing process followed Food and Drug Administration regulations.

Process validation is the collecting of evidence and documentation that shows a vessel is working when the FDA comes knocking.

Stephanie Brandford, Founder, Brayearst Validation Consulting

"Take a water bottle, for example," Brandford says. "That container has some sort of chemical composition in it that will enhance or even save your life as you're drinking water. Then, when you're making large quantities of that product, you need to bring in industrial equipment, which the FDA requires to be running properly. Does the mixing tank need to be cooled or heated? Is there a certain mixing speed? Process validation is the collecting of that evidence and documentation that shows a vessel is working when the FDA comes knocking," she explains. Whether it is the bottle itself, the cap, or the label, each aspect of a product has all sorts of parts to the process, emphasizing the importance of validation and compliance, not just the end product.

Later in her career, after Brandford moved on from Becton Dickinson, she noticed that most companies had very compartmentalized roles. One team would be in charge of cleaning, another would be test methods, and another would be contamination control.

To close this gap, Brandford created Brayearst Validation Consulting, a start-up company that aims to use Six Sigma to help life science companies validate their processes and be prepared for audits. She launched it in August 2023. "It's been a fascinating process," she says, "especially since I've been a big company employee for the past 30 years. It's a bit of a learning curve."

Brandford's advice to current students is to take this time on your own to figure out what you like without worrying that you need to get it 100% right at this point. She hopes that her story will be an inspiration for students to focus less on career outcomes and instead invest their time and energy into their specific interests and skills. "When I picked my concentration, it wasn't biomedicine or colloids, polymers, and surfaces, which ended up being the fields I worked in. But, I don't regret choosing computer-aided design because that was where I was genuinely interested," she says.