In this episode of Manufacturing Hub, we welcome Amy Williams, Systems Architect at Skellig, for a deep dive into the world of life sciences manufacturing, a rarely explored but incredibly complex part of the industrial landscape.

From her roots in biomolecular chemical engineering to her hands-on role in Operation Warp Speed, Amy walks us through what it's really like to build and validate manufacturing systems for pharmaceutical and biotechnology applications under FDA regulation. 💊🧪

We explore:
What exactly qualifies as "life sciences" in manufacturing
Why GMP compliance and validation are critical, and how they slow everything down
How Operation Warp Speed succeeded in compressing a 10-year process into months
The role of automation, MES, and DCS in life sciences
Why paper-based MES is still sometimes the fastest way forward (and why that needs to change)
How companies are moving toward digitization, better data exchange, and process analytical technology (PAT)

Amy also shares her thoughts on:
The importance of cross-functional collaboration in regulated environments
Tips for engineers looking to break into the life sciences space
Why owning your control code might be more valuable than you think

If you're in automation, MES, or engineering leadership, and especially if you work in or around FDA-regulated industries—this episode is a must-listen.

🎧 Subscribe for more practical conversations at the intersection of manufacturing, automation, and strategy.

🔗 Connect with Amy: https://www.linkedin.com/in/amy-williams-automation
📚 Book Recommendation: The Technology Fallacy