Onshoring Requires a Plan for Training

Pharmaceutical Technology®’s quality experts, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, got together in December 2025 to talk about one of their favorite topics: training. The pharmaceutical industry often struggles to keep up with a robust number of skilled workers. And recent developments by major pharma companies to bring manufacturing facilities to the United States have made the topic even more complex. Below is Sue and Siegfried’s response to a reader question about training.

Q. My company is building new manufacturing facilities in the US, which will require additional workforce and skill sets. What kind of training is required and how can we deliver that training?

Schniepp:It's exciting news to know that there are going to be new modern manufacturing facilities. I think the question on training is really fascinating. We do keep hearing there is a shortage of workers for these facilities. So, I think there's going to need to be a lot of training fast to bring workers up to date and up to speed to man these new facilities. And I think the whole concept of training has changed from internal, where we did it internally with our little PowerPoint slides and somebody watching, to more virtual. Training has undergone, in the past 20 to 30 years massive changes, and we use artificial intelligence (AI) tools. It's going to be a challenge, because skill sets are different.

Schmitt: We need to talk about delivery. And as you say, there are many more ways to deliver training these days than we had 10 to 20 years ago. You and I, we've been a while in this industry, but certainly we find that almost every day we learn something new, we hear something new we had no idea about, something interesting comes about. So, learning doesn't stop.

When I started in the industry, and I needed to learn all the basics, it was learning by watching, by being told by the people who have been in the industry for a while. It's not so much in the first instance about reading the books or reading the standard operating procedure, reading the instruction. It's a lot about learning from those who've done it before. So, there needs to be a mix. You can't just throw out instructions and give it to people and say, ‘Here, you read, and you understand and you sign off’. You still need some experienced workforce that holds your hand and that guides you through what needs to be done.

Schniepp:I think it's kind of a scary proposition right now there, because there's a couple of things for me that are going on. One is the virtual AI assistance, where you can put somebody in that virtual area, and they can practice. We saw a demo at one of our conferences, and it's pretty amazing how it picks up on your mistakes. I think that's one way of training. I don't know how many companies can afford that, but the scary part to me is there's a lot of different companies jumping into this arena of training, and I'm not so sure that we have a lot of training associated with colleges and universities now.Do the universities have the extra, long-term expertise?

These are new, sophisticated pieces of equipment going into drive the production of these advanced therapeutic medicinal products, and I don't know that everybody jumping into the training game is qualified. So, how do we figure out who's qualified, who's not, and make the best recommendations to, you know, get the most from these activities going on?

Schmitt: There are a lot of providers of training, and you mentioned universities, colleges, and I'm aware that quite a number these days are collaborating with industry all industry associations, be it the Parenteral Drug Association, the International Society for Pharmaceutical Engineering, or others. And as part of this collaboration, I know that some of these institutions have established proper clean rooms and have modern equipment in there, so you can practice hands on, and we're coming back to this point here. Yes, you can learn an awful lot by watching a video, maybe even on YouTube, but it's never exactly the same as if you are gowned up in the room, and you have to behave in the right way. You have to act in the right way. And perhaps coming back to what you said, once you see yourself doing something, you're suddenly surprised. Did I really do that? For that, you don't need very sophisticated equipment. A video camera does perfectly fine. Training should, if possible, also have this feedback loop where either someone observes and gives you feedback. But it's much more impressive if you can see it on the video, and you see for yourself where you slipped up in your process.

Schniepp: I also think companies should take advantage of the factory acceptance training that many of the manufacturers of the equipment offer, because that's a way to get to utilize or to see the equipment as it's being built, and kind of play with it before it gets installed. What do you think about that?

Schmitt: Well, I think it's not just the equipment on the shop floor, but also the manufacturing and laboratory equipment. When you think of some of the new analytical instruments, they are really tricky and require a lot of skills to operate correctly. And again, as you say, there are lots of providers that offer these training courses is hands-on courses, and absolutely, what we are saying is training in-house, definitely, very important, but it's unlikely to suffice. There needs to be other training elements, like external training, training with suppliers, etc. It's a mix of training we suggest here.

Schniepp: I wonder if we look at our workforce now, we have to look at them in a different way and get them different skills. You know, the operator is no longer an operator. He's like the pilot of a sophisticated plane in a way, right? The laboratory people aren't just doing the simple high-performance liquid chromatography that came in 1980. The lab person is working with these really sophisticated, sensitive pieces of equipment. And we need to have the quality assurance professional who has to have skill sets to be able to interpret what the data that's coming in. And we've got AI out there on the floor collecting data, too. We have artificial intelligence, sophisticated equipment, new skill sets, so how do we bring people up to speed on that? I mean, it's a daunting task, in my opinion, how do we measure that they've gotten through this training the skill sets to be able to do the job in this new environment?

Schmitt: Well, this reminds me of the old days when you did a lot more mechanically and by hand. And for example, in formulation, you would often employ bakers, people from a profession where you had to mix things, where they were used, to be precise, with weighing in and mixing consistently and so on.

And you're absolutely right. These days we have so much more automation. So again, it's unlikely that you can find all the skilled workforce on the market who have all the training, who've worked in this environment before. So you will need to train up persons who come from a different environment, from a different profession, and because there is so much automation, perhaps this is where their skills in computer science may be the ideal starting point to get them trained up in using, as you say, a highly sophisticated analytical system or manufacturing system. What you need to look for is, what are transferable skills? Because there isn't just a huge workforce out there that you can just bring into all these facilities and start up from day one. We will need to find transferable skills and skills that are appropriate for the modern facility.