5 Questions With, Stephanie Brandford, Ambassador of Buzz, Validation Consultant, Brayearst Validation Consulting

This article is part of our 5 Questions With series, one of our ongoing People & Places Features. We love it because despite the consistent questioning, the answers are all unique. Be sure to FOLLOW us on LinkedIn to tell us what you think.

1. What did you want to be when you grow up? How’d you get from there to here?

When I was a child, the epitome of a successful career was symbolized by a single object: a briefcase. My father carried one, and I was captivated by its aura of professionalism. Fast forward to high school, where a keen-eyed guidance counselor noticed my aptitude for math and science. She introduced me to the idea of engineering, setting me on a path that led to a major in Chemical Engineering at Carnegie Mellon University.

Even in my early years as a project engineer in the chemical industry, compliance was always on my radar—though back then, it was more about environmental regulations. It wasn’t until I transitioned to the medical device sector that I discovered the compelling world of validation engineering. This role was a perfect marriage of my technical skills and my enduring focus on compliance, now pivoting towards Good Manufacturing Practices (GMP).

With over 20 years of experience, I’ve evolved from an in-house validation expert to the proud founder of Brayearst Validation Consulting. Here, I leverage my engineering background and Six Sigma methodologies to guide life sciences companies through the labyrinth of FDA compliance. My aspiration is to revolutionize the way life sciences companies approach validation, making processes not only compliant but also more efficient and effective.

2. How are you helping to build a more connected community? 

BioBuzz’s mission is simple: to be more connected. Our regionally-focused storytelling, programs, events and experiences create, connect and amplify impact across the life science workforce in growing biohubs. We vibe with people who value community and connection like us. We’d love for you to share how you’re building a more connected community… and any support that you need from our community to continue to accomplish this mission.

At Brayearst Validation Consulting, my mission aligns closely with BioBuzz’s goal of building a more connected community within the life sciences sector. One of the primary ways I contribute is by attending networking events, where I have the opportunity to engage with a diverse range of companies, from fledgling startups to well-established organizations. I also actively participate in online forums dedicated to life sciences, offering insights and guidance in the specialized area of validation engineering.

My role goes beyond simple networking; I aim to raise awareness about the critical importance of validation, particularly in meeting FDA regulations. By sharing my expertise in Six Sigma methodologies and compliance, I assist companies in not only launching their operations but also maintaining them within the regulatory framework. This creates a more secure and reliable landscape for the entire life sciences community.

What I would value from the BioBuzz community is a collaborative effort to amplify the message about the significance of validation in our industry. Through joint webinars, articles, or events, we can make a collective impact that benefits professionals across the life sciences sector.

3. What are currently buzzing about? Anything and everything…   

Right now, there’s a lot that has me buzzing, both professionally and personally. On the professional front, I’m incredibly excited about the offerings we have lined up at Brayearst Validation Consulting. We’re not just providing standard validation services; we’re aiming to revolutionize the way life sciences companies approach compliance. Our focus is on making these processes not only compliant but also more efficient and effective through Six Sigma methodologies.

Beyond client offerings, I’m thrilled about the opportunity to share my expertise on a broader scale. I’m currently writing a book that explores the complexities of validation engineering. This book is designed to serve as a comprehensive guide for both newcomers and seasoned professionals in the field. It’s more than just a professional milestone for me; it’s a way to contribute to the collective knowledge of our industry.

On the personal side, I’m delighted to be resuming in-person events with a nonprofit organization that encourages children’s literacy and creativity. After a long pause due to the pandemic, it’s uplifting to see young minds re-engage with the world of books and imagination. This endeavor is a vivid reminder that the future of any industry, including life sciences, is in the hands of our youth. Encouraging them to embrace literacy and creativity is a cause that’s close to my heart.

4. If you could travel back in time – what early career advice would you give yourself?

OR what career advice would you shout from the rooftops now?  

Never Stop Learning: The life sciences sector is an ever-evolving landscape. Whether it’s staying updated on FDA regulations, mastering new Six Sigma methodologies, or understanding the latest engineering technologies, continuous learning is the cornerstone of long-term success. At Brayearst Validation Consulting, we’re ready to handle a wide variety of technologies and challenges, thanks to our commitment to ongoing education.

Network Early and Often: I can’t stress enough the importance of building a robust professional network. It’s not just about collecting business cards; it’s about forming meaningful relationships that can provide support, open doors, and offer fresh perspectives. Networking has been instrumental in my journey, from my days at Carnegie Mellon University to the founding of my consulting firm.

Invest in Soft Skills: While my background in chemical engineering provided me with the technical skills to excel in validation, it’s the soft skills like communication, leadership, and emotional intelligence that have truly rounded out my professional profile. These skills are often underestimated but are crucial for effective client interactions and team collaborations.

5. FUN question. Comics! In celebration of National Comic Book Day, if your life was a comic book… what would it be?!

Panel 1: A bustling life sciences lab, machines humming, scientists busy at work. The atmosphere is tense, filled with the weight of looming deadlines and regulatory pressures.

Caption 1: “In a world where the stakes are high and the regulations even higher, one woman stands at the crossroads of technology and compliance.”

Panel 2: Our hero, now known as MethodMaven, calmly walks into the lab. She’s armed with a briefcase—the same symbol of professionalism that inspired her as a child.

Caption 2: “Meet MethodMaven, a chemical engineering prodigy turned validation virtuoso. With her Six Sigma methodologies and an unwavering focus on compliance, she’s the last line of defense against the forces that threaten the life sciences industry.”

Panel 3: Villains representing Complacency, Confusion, and Non-Compliance, lurking in the shadows, plotting to disrupt the order of things.

Caption 3: “But even heroes have their adversaries. Meet the villains of our story: Complacency, a sly entity that lulls companies into a false sense of security; Confusion, who thrives on creating chaos with complex regulations; and Non-Compliance, the most dangerous of them all, risking not just reputations but lives.”

Panel 4: MethodMaven in action, effortlessly navigating through a maze of regulations, solving complex validation puzzles, and leading a team with poise and wisdom.

Caption 4: “Armed with her knowledge and guided by her wisdom, MethodMaven is on a mission to bring clarity to confusion, instill diligence over complacency, and ensure compliance overall.”

Panel 5: MethodMaven, standing victorious, as the lab transforms into a beacon of efficiency and compliance.

Caption 5: “In this epic battle between order and chaos, only one can prevail. Will MethodMaven succeed in her quest to revolutionize the life sciences industry? One thing’s for sure: she’s ready for the challenge.”