Design, Build and Deliver
Welcome to Design, Build, and Deliver with Hart Companies where we dive deep into the world of life science with leaders who decide, design, and deliver the next generation of pharma and biotech facilities. Join your host, Samir Gondalia, as he interviews visionary leaders shaping biotech and pharma facilities from C-suite executives to project decision makers. Hear real stories, industry trends, and actionable insights to help you build your facilities and career smarter, faster, and better.
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Episode 3 - Jimmy O'Keefe and Navigating Life Science Capital Projects
10/23/2025
Episode 3 - Jimmy O'Keefe and Navigating Life Science Capital Projects
My guest in this episode is James O'Keefe. James is Vice President at Hart Engineering Corporation, where he oversees complex mechanical construction projects across the life sciences, pharmaceutical, and industrial sectors. Since joining Hart in 2008 as a Northeastern University Co-Op student, James has advanced through multiple engineering and project management roles. From a Co-op to VP - a real example if you need one. With nearly 20 years of experience, he has led some of Hart’s most demanding installations in New England. He is deeply engaged in advancing life science industry standards through active participation in the New England Mechanical Contractors Association (NEMCA), the International Society for Pharmaceutical Engineers (ISPE), and the UA Local 51 Joint Apprenticeship Training Committee (JATC). Jim holds a degree in Mechanical Engineering from Northeastern University. In this chat, Jim and I delve into - the intricacies of capital projects, - the differences between design build and design assist methodologies, - the importance of various drawing types in project management, - strategies to avoid delays and cost overruns, and - the growing trend of local sourcing in the life science construction industry. Additionally, we address the critical shortage of skilled labor and the value of apprenticeship programs, while also touching on personal insights regarding work-life balance and the importance of effective communication in project execution. Takeaways: Design build integrates engineering and contracting under one entity. Design assist involves contractor input during the design phase. Different drawing types serve specific purposes in project management. Early conversations with stakeholders can prevent project delays. Local sourcing is becoming more popular for better control and quality. Choosing the right materials can lead to significant cost savings. The construction industry faces a shortage of skilled labor. Apprenticeship programs provide valuable education without debt. Work-life balance is essential for long-term career satisfaction. Quatable Quotes: "It's a lot easier to change things on paper than in a facility." "We can streamline everything." Jim can be reached at jokeefe(at)hartcompanies.com and on LinkedIn. I found my discussion with Jim very timely and insightful. I hope you do too. Here's James O'Keefe.
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Episode 2 - Michael Kelly and the Future of Pharmaceutical Facilities
10/17/2025
Episode 2 - Michael Kelly and the Future of Pharmaceutical Facilities
My guest in this episode is Michael Kelly. Mike is the Director of Bio-process Engineering at Hart Design Group, where he has been leading innovative process solutions. With a career spanning top-tier biotech and engineering firms like Parsons Corporation, Biogen, Amgen, and Moderna, Mike has held increasingly senior roles across engineering, project management, and facilities operations. He has a degree in Chemical Engineering from Widener University, and an MBA from Bentley University. He brings technical acumen along with strategic thinking which were abundantly clear in this interview. Michael enjoys traveling, ice hockey, golf, and a good book. In this chat, Mike and I discuss - the evolving landscape of the pharmaceutical industry, - the facility retrofitting and the integration of new technologies, - the importance of flexibility in facility design, - the role of innovative tools like 3D scanning and augmented reality, and - the challenges of managing operations during retrofitting. Takeaways The pharmaceutical industry is shifting towards retrofitting existing facilities rather than building new ones. Flexibility in facility design is crucial to accommodate various modalities and future needs. 3D scanning technology enhances the retrofitting process by providing accurate facility layouts. Logistics planning is essential to minimize disruptions during facility upgrades. Underrated causes of delay often stem from site conditions and communication issues. Choosing an engineering partner with in-house capabilities can streamline project execution. Proactive planning is necessary to avoid disruptions in GMP operations during retrofitting. Collaboration with trades and construction teams is vital for successful project outcomes. Utilizing augmented reality (AR) can improve rigging and installation processes. Future-proofing facilities requires anticipating scientific advancements and designing accordingly. Quotable quotes: "It's all about time and money." "Logistics planning is crucial." Additionally, we highlight underrated causes of project delays and provide insights on how life science companies can choose the right engineering partners to ensure successful project execution. Mike can be reached at mkelly(at)hartcompanies.com and on LinkedIn. I enjoyed my chat with Mike. Hope you do too. Here's Michael Kelly.
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Episode 1 - David Rampone and Life Science Industry Changes and Challenges
10/17/2025
Episode 1 - David Rampone and Life Science Industry Changes and Challenges
My guest in today’s episode is David Rampone, a leader whose impact extends far beyond engineering and construction. David is President of Hart Engineering Corporation. He has spent decades not just building facilities - but building trust, excellence, and a legacy of craftsmanship that stands the test of time. David’s leadership reaches deep into the heart of Rhode Island and the life sciences industry. In addition to guiding Hart Engineering, he serves as Chairman of the Miriam Hospital Foundation Board of Trustees, and chairs or sits on the boards of numerous education, labor, safety, trade, and charitable organizations. In our conversation, David and I talk about how timeless organizations are built - not through slogans, but through integrity, rigor, and relationships. David shares what it really takes to get life science facility projects done on time and under budget, why some projects succeed while others stall, and the biggest - and most avoidable - causes of delays. Takeaways The original Hart Engineering was formed in 1942 and has evolved significantly since then. Industry changes have led to incomplete construction documents, complicating project budgeting. Accurate project planning can save millions in costs and time. Building a strong company foundation relies on hiring dedicated and honest people. Long-term career success involves broadening horizons and understanding team needs. Involvement in industry associations enhances professional relationships and knowledge. Strong relationships with labor unions foster mutual respect and collaboration. Life lessons from golf emphasize patience and resilience in business. Work-life balance is crucial for long-term success and personal well-being. Quotable quotes: "We have a thing called the 10 Hart ideals." "Don't stay in your own little silo." "Work is not your whole life though." For anyone leading or managing facilities and capital projects in life science, this episode is packed with practical wisdom earned through decades of real-world experience. So, whether you’re a facility leader, an engineering manager, or just someone who appreciates the art of building things that last - this conversation will give you a rare inside look at how great projects, and great organizations, come to life. David can be reached at drampone(at)hartcompanies.com. I enjoyed and learned a lot from my chat with David. Hope you do too. Here's David Rampone.
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