Brielle Reisman, Account Manager, recently sat down with Pharma Control Systems Expert Alison Dopler to discuss some of the challenges and lessons learned throughout her career.
From building greenfield pharmaceutical facilities to training the next generation of engineers, Alison Dopler has achieved many milestones since we first worked together as junior engineers on a filling line upgrade project 6 years ago. She manages projects of all sizes and complexities in Life Sciences, specifically Pharma, and recently completed a major milestone – Installation Qualification, Operational Qualification (IOQ) of a greenfield project.
With a background in chemical and bioengineering, Alison has always felt a calling towards Life Sciences. Her passion for projects with real impact led her to build a portfolio of expertise in the pharmaceutical industry and become one of ACE’s Subject Matter Experts (SMEs).
I sat down with Alison to ask her about some of the challenges she’s encountered, and any lessons learned to share with other engineers.
When asked about her favorite project, Alison doesn’t hesitate: The Greenfield Pharmaceutical site she ran as a technical lead.
“I got to see the project from the very beginning when we were standing in a field with just steel beams going up. Now it’s a state-of-the-art facility preparing for future pandemic response.”
Alison served as the technical lead on the automation side, overseeing everything from batch management systems to formulation suites. This project also had a special team dynamic: a mix of junior and senior engineers, many of whom were new to pharmaceutical.
“Watching them learn, take charge, and assimilate into the client’s team was truly remarkable. I saw them jump in to support the process engineers on site, getting hands-on with tubing, valves, and commissioning. It was one of the most gratifying experiences I’ve encountered.”
For Alison, success in pharmaceutical projects comes down to being detail oriented.
“You must be willing to adhere strictly to established procedures without taking shortcuts. You also need to be flexible. Every client has different protocols and formats, even though they all follow GMP (Good Manufacturing Practice). Asking the right questions upfront about templates, protocols, and quality review can save months of rework.”
She also explains that in a GMP environment, every change, no matter how small, needs to be documented, approved, and validated.
“You can’t just decide to add a valve or tweak a line of code. Everything has to align with the approved design documentation. That’s why we follow the V-model so closely. It ensures traceability from user requirements to final validation.”
She says that one of the most difficult parts about training new engineers on pharmaceutical projects is having to curb their excitement to immediately dive into the software and start programming.
“They’re eager and enthusiastic but I remind them that the documentation is the most important part. It might feel tedious, but if you don’t build the right foundation, the entire system is at risk.”
She also believes that being part of a strong, multi-disciplinary team makes all the difference.
“We’re not just controls engineers, we’re working with validation, production, QA, and project management. Everyone has their own priorities, and a successful project depends on bringing those together.”
I asked Alison what the biggest challenge is in the projects she has worked on.
“Trying to decide when the right time is to lock down, test, and leverage the code”
Alison emphasizes that you shouldn’t lock down your code too early.
“My rule of thumb: don’t lock it down until post-FAT. You want the flexibility to adapt during testing and change control can slow you down if it’s too soon. Requirements will change while you are programming the system, and you have to be able to incorporate them without too much rework.”
ACE has developed internal tools to help incorporate these changes more seamlessly. One of the most innovative tools Alison has used is a phase generation tool that automates the creation of control modules and writes actual values into the tags.
“It saves so much time and reduces human error. And on a big project, those time savings compound fast.”
Another challenge in Pharma is balancing engineering requirements, validation, and the capabilities of the chosen software. Alison recalls a time the site engineers wanted to build in a “manager approval” screen for certain operator actions on the HMI. The chosen software didn’t have this natively so many questions came up, such as:
Pharma is slow to change and that is on purpose. While other industries might jump at the latest AI tools or software updates, pharma moves with extreme caution. Alison explains why:
“Validation is everything. You can’t just roll out a new version of Wonderware because it exists. In fact, we were upgrading a system to Wonderware 2017 in 2024 because that’s how long it takes to validate a system to GMP standards.”
She sees a growing challenge in balancing regulatory compliance with innovation. AI, for example, is a hot topic but may not be embraced by Pharma for a long time.
“You can’t validate something if you don’t know how it arrives at an outcome. That’s a huge barrier in pharma.”
Cybersecurity is another concern, especially when proprietary process data is a company’s biggest asset.
“We’re moving toward more connected systems, but with that comes the need for strict OT/IT security.”
“A lot of people are intimidated by pharma,” Alison says. “They think it’s too structured or has too much red tape. But once you’re in, you realize it’s one of the most collaborative, rewarding spaces in engineering.”
She encourages new grads not to shy away.
“You’ll learn so much — not just technically, but about how automation plays into the overall project. Teams come together to make the project a success and learning to navigate that is a skill that will benefit you in your career.”
Whether she’s managing rigorous project schedules, training new engineers, or navigating the fine print of GMP documentation, Alison ensures that a culture of trust, communication and mentorship is always present among her team. Her success proves that great automation isn’t just about programming but about overcoming challenges along the way and learning from them.
Learn more about ACE’s solutions for the Pharma Industry.
Interested in working for ACE? Visit our Careers page.