Ask the Expert: Training for a Skilled Workforce

Geopolitical stressors, such as trade policies put in place by the Trump administration in the United States, have pushed some pharmaceutical companies to invest in moving production and building new facilities in the US (1). With expansion, however, comes the need for qualified personnel to run operations in these manufacturing facilities.

But the industry has been struggling in recent years in obtaining the personnel with the proper skill sets to meet demand. And because pharmaceutical development and manufacturing are regulated industries, training personnel is crucial to ensure safe and effective medicines reach the patients that need them. So how can pharma companies ensure their staff, new and current, are up to speed on the latest tools, processes, and regulations?

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt, PhD, VP Technical at Parexel, delve into the complexity of training in this episode of Ask the Expert.

“I think the question on training is really fascinating, says Schniepp. “We do keep hearing there is a shortage of workers for these facilities. 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 last 2030, years, massive changes, and we use AI tools.”

“We need to talk about delivery [of training],” Schmitt stresses. “There are many more ways to deliver these days than we had 1020, 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. And the other thing that I certainly look back to when, when I started in 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. So, 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, I'd say. 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.”

Click the video above to watch Sue and Siegfried answer the following question:

“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?”

Reference

1. Cole, C. How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains. PharmTech.com. Sept. 26, 2025. https://www.pharmtech.com/view/how-100-pharmaceutical-tariffs-will-impact-domestic-manufacturing-and-supply-chains

About the experts

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Ask the Expert Video Series

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to PTProjects@mmhgroup.com, and it may appear in a future episode or print column.

We hope you enjoy the discussion!