Achieving Quality
The third edition of our series is focused on achieving quality. Life sciences facilities are among some of the most complex facility construction projects. Combined with strict regulations from government and regulatory agencies, as well as robust design standards and intensive client expectations, attention to quality demands a thorough plan and constant attention to construction details. Our builders understand how quality ensures compliance and, above all, safety in your facility. We asked our experts, when working on a life sciences project, what do you do differently to ensure the project will meet the rigorous quality requirements and expectations?
Chris Barry
Preconstruction Executive
“There’s always something new and innovative coming out of the life sciences – and quality expectations, while always high, vary from project to project. The key to achieving quality is really about understanding our individual client’s business need. With a clear understanding of client expectations, we can ensure alignment of priorities and critical aspects, and enforce the correct application of the requirements, standards, and licensure criteria.
Focusing on the unique business requirements really dictates our strategy in terms of being able to deliver to our clients’ expectations. We’re able to leverage our relationships in the market specifically to suit the specific quality, safety, cost and budget objectives, as well as the program needs of the client. We know which firms can execute the level of quality necessary for that client and project – so that we can be certain quality is never sacrificed while at the same time, ensuring competitive engagement from the market.”
With more than 33 years of experience in preconstruction management, Chris collaborates closely with both public and private life sciences clients from pharmaceutical to academic.
Jose Jimenez
Vice President, Life Sciences COE Leader
“Lean construction principles enhance a project’s safety, quality, budget, and schedule outcomes. Early contractor engagement, design-assist, prefabrication, and modularization all support speed to market which is so critical for facilities that support new drug discoveries and manufacturing operations. These initiatives also alleviate on-site workforce demands while increasing safety and quality. Some examples of solutions we are implementing for our life sciences clients include prefabricated skid assemblies for building utilities and clean utilities, and panelized or modular clean room systems. These construction techniques allow quality control checks earlier in the process, and minimize issues and delays on site.”
In his role as vice president and life sciences center of excellence leader, Jose supports Gilbane’s life sciences clients and project teams with speed to patient goals, and a focus on safely delivering quality facilities.
Michelle Leonard
VDC Director
“With life sciences projects, we need to be inquisitive! The process going on in the facility is unique. No two projects are exactly the same. From the VDC perspective, I want to learn about how the building systems and equipment will be used, so I can make informed decisions to effectively coordinate these buildings’ really complicated systems knowing how they interrelate, and how they will be operated. What clearances are needed? How will you be physically using the equipment? What are your access needs? What are the cleaning requirements? The answers to these (and many other) questions will help us ensure the construction coordination process meets the requirements of the science. VDC is all about first “building” the building virtually to prepare us for construction … so the quality of the completed facility is directly enhanced by our coordination process through communication, collaboration and transparency.”
In addition to her VDC expertise, Michelle is a licensed architect and as such brings the designer’s perspective to her partnerships with life sciences clients.
Scott Machinski
Senior Project Manager
“I have spent many years working for various life science clients directly. When it comes to quality, I’ve adapted some common best practices in Life Sciences construction. An example of a good practice when we’re building a cGMP manufacturing facility is to set up dedicated clean fabrication areas, including “Kitting areas,” on site where all product-contact or hygienic material needed to build a level #1 or #2 system is received, inspected and qualified back to vendor certifications. Once qualified, the material is categorized by type or by system, then shelved until needed. As the project progresses, we pull from this material and reorganize it into smaller working shelves that include all the raw material, instruments, inline devices, to complete a particular isometric which could have multiple line numbers. Applying this very simple concept ensures the quality of our end product and minimizes the risk of using the wrong material prior to installation.”
Scott brings nearly 25 years’ experience with a focus on life sciences, including experience on the owner’s side of the table.
Katie Strumolo
Preconstruction Director
“When we talk about quality, we often talk about prevention versus correction. And often people will think about that in terms of construction quality compliance – catch an issue early, so that we do it right the first time. But really, we are applying that concept into preconstruction – catch an issue before it happens – so you don’t have to correct it at all. In life sciences, you know quality can’t be compromised, yet you have a conflicting need for speed to market, so the focus on quality before a shovel hits the ground becomes even more crucial. Then you add in the pace of advancements in the science and technology, and achieving quality becomes a bit about having a crystal ball. You need to be able to think into the future, be aware of the future changes coming to the market, so you can support the client to make the best decisions that integrate flexibility to accommodate change – that will likely happen before the facility is even complete. By doing that, you double the impact – integrate flexibility and also avoid re-work, which is another huge factor in ensuring quality.”
During her 17-year tenure at Gilbane, Katie has held various preconstruction roles, and has supported more than $600 million of life sciences projects varying from adaptive re-use to new construction.
To learn more about our experience, including laboratory spaces, clean rooms, cGMP manufacturing and pilot plants, click here to visit our website or click here to contact our specialists!
