David Mierau, PE- Vice President, Life Cycle Engineering
If there’s one thing we’ve learned over the last few years, pharmaceutical manufacturers are being asked to do more with less time, fewer resources, and tighter space. The push to expand production and respond to market needs quickly, while still meeting strict compliance standards, has made life on the plant floor much more complicated.
But here’s the good news: we don’t always need to build brand-new facilities to meet that demand. Some of the most successful strategies come from companies that double down on what they already have, whether retrofitting underused areas or getting more from their existing equipment and teams. The key is to bring a sharper focus to how we operate, not just where we operate.
At Life Cycle Engineering (LCE), we’ve spent decades helping manufacturers in the pharmaceutical space make their facilities more efficient, reliable, and ready for whatever’s next. And while the challenges keep evolving, the principles behind good operations haven’t changed. Below, I’ll walk through what we’re seeing in the field, including what’s working, what’s getting in the way, and how we can all move forward with intention.
Expanding Capacity Without Breaking Ground
Let’s start with a big trend: companies are looking for faster ways to bring new products into commercial production. Building a new facility from scratch can take years, not to mention the cost. So instead, many are focusing on how to make the most of the sites they already have.
One example that comes to mind involves a large biologics manufacturer that needed to scale up production fast. Instead of building new, they identified unused space in one of their existing plants and brought us in to help convert it for the new process. We worked with their team to get everything up and running, from reconfiguring equipment and improving asset performance to making sure operations were ready to go. These are asset-intensive operations that need significant focus on asset management and equipment details to ensure optimized operations and maintenance procedures are built.
The result? They hit full production six months ahead of schedule, without the long delays or expense of new construction. It worked because they approached the project with a mindset of operational readiness from the beginning, not as a box to check at the end, but as something baked into every step of the process.
What’s Holding Pharma Facilities Back?
Even with the best intentions, many facilities run into the same kinds of issues. Here are three common operational roadblocks we see, nd more importantly, how to start tackling them.
1. Systems That Don’t Talk to Each Other
It’s not unusual to walk into a plant and see critical systems such as maintenance tracking, production monitoring, and quality assurance all running separately. Without integration, it’s tough to get a full picture of what’s working and what’s not. Decisions get delayed, important data gets lost, and improvement efforts stall out before they begin.
2. Reactive Maintenance
Too many teams are stuck in firefighting mode, fixing equipment after it breaks rather than staying ahead of the problems. That reactive mindset leads to more downtime, higher costs, and a greater risk of compliance issues. What’s often missing is a clear plan for preventive maintenance, including training operators to handle some of the everyday care tasks that keep equipment in good shape.
3. Inconsistent Standards from Site to Site
If your company has multiple facilities, odds are they all do things a little differently. While some flexibility is natural, big differences in how things like maintenance, training, or data management are handled can make it hard to scale and improve consistently across the organization.
What’s Changing for the Better?
Despite the challenges, we’re seeing some exciting shifts in how pharma companies think about their facilities and how operations teams are stepping up to lead real change.
1. Operational Readiness Is Becoming a Priority
It used to be something saved for the final phase of a project. Now, more companies are weaving readiness into every stage, such as design, commissioning, training, and beyond. That means better planning, fewer surprises, and smoother startups. It means analyzing equipment risks, evaluating redundancy needs, ensuring needed maintenance access is provided in layouts for efficient future work execution, and setting up asset master data as early as possible.
2. Smarter Use of Data
By cleaning up their asset master data and connecting it across systems, teams can finally get reliable insights into equipment performance and make smarter decisions about where to focus their time and budget. One client we worked with boosted equipment uptime by over 20% within a few months by bringing better visibility into their maintenance program. Prioritization is key for determining where to deploy your limited resources.
3. Embracing Total Productive Maintenance (TPM)
This is one of the biggest mindset shifts we’re seeing: treating maintenance not as something that happens to the equipment, but something that’s shared across the whole team. TPM brings operators into the picture, gives them ownership, and helps spot small issues before they become big ones. It also builds a stronger culture of accountability and pride on the shop floor.
How to Turn Strategy into Real-World Wins
So how do you take all of this and apply it in your facility? Here are a few things we’ve seen work time and again.
Start With the Basics
Before you chase big tech solutions, take a good, hard look at how your teams are currently operating. Are maintenance tasks documented clearly? Are operators empowered to take action? Are roles and responsibilities well understood? You’d be surprised how many problems can be solved by cleaning up the foundation.
Involve Operators Early
One of the most impactful things we do is help train operators to take on routine maintenance tasks such as cleaning, checking, tightening, and inspecting. Through interactive workshops, they learn not just the “what” but the “why,” including how equipment works, how to spot early warning signs, and how to prevent problems. And because the output of these workshops is a set of new operator care procedures, the gains are both immediate and lasting.
Use Data to Prioritize What Matters
When resources are limited, you can’t fix everything at once. That’s why we focus on reliability risk evaluations and asset criticality assessments. These help you assess which equipment is most essential to your process, where the biggest risks lie, and what actions will bring the most value.
Align Standards Across Sites
If you operate multiple facilities, find ways to standardize the essentials like your asset hierarchy, maintenance strategies, and training programs. It makes it much easier to scale best practices, measure performance, and move people or products between locations without skipping a beat.
Final Thoughts
Pharma facilities are under more pressure than ever to be fast, flexible, and reliable. That’s not easy. But I believe that with the right operational strategies that put people, processes, and data together to work in smarter ways, we can meet those demands without burning out our teams or breaking our budgets.
The key isn’t just more automation or more equipment. It’s about making better use of what we already have, building strong foundations, and creating a culture where everyone, from leadership to line operators, plays a part in making things run better.
At LCE, we’ve seen what’s possible when companies invest in their operations, not just as a cost center but as an investment, a true enabler of growth and innovation. And I think that’s the thinking we need more of as we look ahead to the next chapter in pharma manufacturing.
Author Biography
David Mierau, PE, is Vice President at Life Cycle Engineering (LCE), where he leads initiatives focused on improving reliability, reducing downtime, and building smarter operations across manufacturing and life sciences organizations.
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