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5 Questions With Nathan Roman, Director, Validation at Genesis AEC

5 Questions With…” is a recurring BioBuzz series where we reach out to interesting people to share a little about themselves, their work, and maybe something completely unrelated. This week we welcome Nathan Roman, Director, Validation at Genesis AEC.

Nathan Roman is an accomplished expert in equipment commissioning, qualification, and validation, including temperature mapping studies, with more than 22 years of experience in the field. In his role at Genesis, Nathan manages a team of subject matter experts and is responsible for developing business, managing and growing teams, and delivering services for a portfolio of customers. Nathan’s expertise lies in helping people in the Health & Life Science industry ensure compliance with current regulations when carrying out commissioning, qualification, and validation projects. With a wealth of experience placing thousands of temperature sensors in hundreds of control temperature chambers, Nathan continuously improves his processes for faster delivery of fully qualified chambers for use.

Over the years, Nathan has spent a considerable amount of time performing controlled temperature chamber equipment qualifications, providing temperature mapping training and education, partnering with equipment vendors, and providing guidance and consultation around temperature mapping services. Nathan’s passion lies in helping those who must perform temperature mapping understand how to map, where to place sensors and why, and how to qualify their temperature-controlled equipment. He provides simple, timeless, proven, and practical tools to achieve these tasks.

Stay up-to-date with Nathan’s journey by following him @nathanroman on LinkedIn. Reach out to him if you’re interested in learning more about the commissioning, qualification, and validation services he can provide.

1) Please introduce yourself to our audience by looking back at your education, training, and career path.

Hello, my name is Nathan Roman. I am driven by a passion to help others and bring value to their lives. Whether working alone or as part of a team, I thrive in creative and adaptable environments that enable me to fully work within my unique abilities. My expertise lies in helping individuals and organizations implement temperature mapping studies and equipment qualifications in order to meet regulatory requirements.

I began my career as a computer-aided draftsman in the aggregate industry, where I prepared detailed plans and drawings for the manufacture and erection of steel used in the construction of quarry plant structures. However, my uncle, who was a consultant in the pharmaceutical industry, asked for my help with a project, and that was my first exposure to the pharmaceutical world. I later began my entrepreneurial journey in 2007 when I joined my two cousins Mark and Tom O’Donnell, as a partner in a Life Sciences professional services start-up, which grew to $30 million in under 10 years and we made the Inc 5000 list 5 years in a row.

With over two decades of experience, I have provided commissioning, qualification, and validation services in the Health and Life Sciences industry, with a focus on temperature mapping studies and equipment qualifications. My goal is to better inform and guide those who aim to meet regulatory requirements in this field. Over all these years, I have gained a wealth of knowledge and experience in the field. My experience has been rewarding, and I have enjoyed working hand-in-hand with customers to achieve their goals.

2) You’ve been with Genesis for about 4 years – what do you enjoy most about the company, and what are you looking forward to in the year ahead?

As someone who has had the opportunity to work at Genesis, I can confidently say that what I enjoy most about the company is the strong culture of growth and the sense of community within the organization, which aligns perfectly with my passion for creating a productive environment. Genesis truly values its employees and offers top compensation and benefits, as well as opportunities for career advancement and professional development.

The life science clients and projects we work on are exciting and fulfilling, as they make a real difference in the world. I appreciate that my experience in the field has been rewarding and I have enjoyed working hand-in-hand with customers to achieve their goals. Looking forward to the year ahead, I am excited to see how Genesis continues to grow and adapt to new challenges while maintaining its focus on employee well-being and professional development, as it aligns with my goal to better inform and guide those who aim to meet regulatory requirements in this field.

With the leadership team’s dedication to creating a positive impact on our clients and employees, I have no doubt that Genesis will continue to be a great place to work and build upon my experience.

3) What are some trends that you’re seeing the Life Sciences Technical Services/Validation space right now? What kind of things are your clients asking for?

As an expert in temperature mapping, one trend that I’m seeing in the Life Sciences Technical Services/Validation space is the increased emphasis on data integrity and regulatory compliance. Companies are placing a greater emphasis on ensuring that their processes and equipment are fully validated, and that they meet regulatory requirements. This is especially true in areas such as temperature mapping studies and equipment qualifications, where the data collected is critical for ensuring product quality and safety.

Another trend that I’m seeing is the use of advanced technology in the validation process. This includes the use of advanced software and sensors to collect and analyze data, as well as the use of predictive analytics to identify potential issues before they arise. Additionally, there is an increasing focus on the use of automated processes to streamline the validation process, which can help to reduce costs and improve efficiency.

Finally, there is an increasing focus on sustainability and reducing the environmental impact of the Life Sciences industry. Clients are asking for validation services that take into account the environmental impact of their processes and equipment and are looking for ways to minimize waste and energy usage while maintaining regulatory compliance. This is an exciting trend, and one that I am personally passionate about, as it aligns with my own values and goals as a professional in this space.

4) Talk us through the Genesis project process and how the company works with its clients.

At Genesis, we understand the importance of efficient project management and take a proactive approach to project processes. By identifying and resolving issues early on, we minimize the risk of costly changes and delays during construction, installation, and CQV. As a company, we have expertise in the design and construction of capital design/build projects and work closely with our health and life science clients to ensure that all elements of the project are integrated and aligned to achieve project objectives efficiently and effectively.

One of our main service offerings is Commissioning, Qualification and Validation, and we share the knowledge we’ve gained having worked for many companies and on many types of equipment and systems within GxP-regulated industry. Our clients often benefit from our flexible staffing solutions or temporary added human resources, which come pre-equipped with the relevant expertise. With an owner mentality, we take responsibility for all aspects of the equipment and project, breaking down barriers to ensure that our clients can stay focused on operations and scale up as needed. This creates added value and builds long-term relationships with our clients.

5) Now for the fun question – if you could be in any fictional universe, be it from a TV show, movie, video game, etc, which universe would you choose and why?

If I could travel through time to any fictional universe, it would be the one depicted in the movie “Back to the Future”. Not only is the concept of time travel fascinating to me, but the film also presents a fun and entertaining version of what the past and future might look like. I would love to see the 1950s, travel back to 1980s, and definitely go see the future depicted in the movie, and maybe even interact with the me of the future. Plus, who wouldn’t want to ride in a DeLorean time machine?

Originally posted by BioBuzz.

About Genesis AEC

Genesis AEC – an award-winning consulting, architecture, engineering, and construction management firm – has partnered with life sciences companies for more than 25 years to complement the scientific expertise of our clients as they usher in the next generation of life-saving therapies, treatments, and technologies. Whether it’s providing AE support for existing sites; commissioning, validation, and qualification (CQV) for specific processes or equipment; or turnkey design-build solutions, our team blends sound science and technical expertise with quality assurance and safety measures to deliver unparalleled results.