Written by Alex Broadbridge, Business Manager for Automation & MES Engineering
Eli Lilly and Company has committed more than $50 billion to US manufacturing since 2020, spread across four new plants announced in the last eighteen months alone, in Virginia, Texas, Alabama, and most recently Pennsylvania, where the company pledged $3.5 billion for a new site in the Lehigh Valley. But they're not alone in this build-out. Pharma companies have pledged more than $370 billion in US manufacturing investment over the next five years, with Johnson & Johnson, Merck Group , Roche , AstraZeneca , Novartis , and Sanofi all announcing multi-billion-dollar domestic expansions.
But none of that spending guarantees a plant ships its first vial on schedule. Dollar figures and job counts describe the investment. They don't describe what it actually takes to bring a facility online.
A pharmaceutical plant is not operational the day construction finishes. It becomes operational once its control systems are built, tested, and validated.
Every modern pharma facility runs on three layers of automation, stacked on top of each other.
At the bottom sits PLC, the programmable logic controllers that run individual pieces of equipment, such as a bioreactor, a fill-finish line, or an autoclave. Each piece of equipment needs code that tells it exactly what to do, when to do it, and under what conditions.
Above that sits SCADA, the supervisory layer. This is what lets an operator monitor and control dozens of machines from a single screen instead of walking the floor and checking dials by hand.
At the top sits MES, the manufacturing execution system. This layer runs the actual production process end to end, covering recipe management, work orders, and, critically for pharma, electronic batch records. In a GxP-regulated environment, MES is what proves a batch was made correctly, by the right process, with a complete audit trail. Without it, a batch does not exist as far as the FDA is concerned, regardless of how much product came off the line.
None of this exists on day one of a new build. It has to be designed, coded, tested, and validated before the facility can produce anything a patient will ever take. On a greenfield site like Eli Lilly's four new plants, that means building the entire stack from scratch, in parallel with construction, against a regulatory standard that allows no shortcuts.
This is not generic industrial automation. Building control systems for a pharma plant means working inside GxP and FDA 21 CFR Part 11 requirements from the first line of code. The people who do this work sit in four distinct and hard-to-substitute roles.
Controls and PLC engineers program the equipment layer for GxP-validated environments. SCADA and automation engineers build the supervisory systems that operators rely on every day. MES engineers implement platforms such as Werum PAS-X, Rockwell PharmaSuite, or Siemens Opcenter, and configure them for electronic batch records. CSV engineers validate that every one of these systems meets regulatory requirements before a single batch can run through them.
All of these disciplines are required, and all of the work happens before commercial production starts. Miss one, and the plant will not open on time, no matter how well the construction is progressing.
Two things are moving in the same direction at once. Regulatory expectations around data integrity and AI oversight continue to rise. The FDA published draft guidance on AI in regulatory decision-making in January 2025, followed by joint FDA-EMA guidance on AI in drug development a year later, and the European Commission now has a draft GMP annex under consultation that specifically addresses AI-supported validation. The bar for what a validated control system needs to demonstrate keeps climbing.
At the same time, the broader manufacturing workforce is aging out. Industry commentary in adjacent sectors such as chemical manufacturing points to roughly a quarter of the existing workforce becoming eligible to retire within five years, taking process knowledge with them that was never fully documented. Pharma manufacturing draws from the same talent pool and faces similar demographic pressure. Construction firms building these plants are already flagging labor shortages as the leading cause of project delays across the sector.
Rising compliance requirements and a shrinking pool of experienced people to meet them are combining to create the real constraint on how fast this manufacturing boom translates into working plants.
These new facilities represent a genuine vote of confidence in US pharmaceutical manufacturing, and they will create real capacity once they come online. But capacity is not square footage. It is a validated, functioning control stack, built by a small number of specialists who understand both automation engineering and pharmaceutical compliance well enough to satisfy a regulator.
Building this stack takes specialist engineers who understand both automation and pharmaceutical compliance, and they are hard to find. If your team is trying to fill these roles, we can help.
