Meet Dain Hughen – Director of Validation at Argonaut
What’s a day in the life of a Director of Validation at Argonaut?
“There’s a plan every morning, and then there’s what actually happens,” Dain Hughen says with a smile. He oversees validation and metrology across utilities, manufacturing equipment and systems, and QC—making sure every system is suitable for its intended use and that processes are reproducible and consistently meet quality attributes. A typical day blends compliance checks (calibration and requalification on set frequencies), documentation (writing/condensing protocols and reports), and real-time triage across projects. “As a CDMO, new clients and equipment arrive with their own timelines, so it’s a juggling act to keep current operations compliant while prioritizing what truly needs to happen right now,” Dain Hughen shares.
How does your work support Argonaut’s mission?
“Before we even get into cGMP manufacturing, everything has to be onboarded and appropriately tested prior to use,” Dain Hughen explains. This means making sure equipment is calibrated, qualified, and on a preventive maintenance schedule, so operations start from a state of control. “You can’t add quality by testing—you have to build quality in from the ground up.” Validation gives the Argonaut team confidence that the end result will meet customer requirements and, most importantly, be safe for patients.
What does “quality built in” mean to you?
“It starts with understanding how systems and equipment are meant to be used, and then demonstrating—through documentation and testing—that they will perform as required,” Dain Hughen says. In other words, building quality into the process means making sure requirements, specifications, and regulations are directly tied to how the product is actually made.
“You can’t add quality by testing—you have to build quality in from the ground up.”
What challenges do you navigate day to day?
“People and schedules,” he says candidly. Meetings can involve a lean startup one hour and a large, structured organization the next—“you have to quickly decide whether to listen and execute or lead the conversation.” Operationally, dependencies can ripple. For example: “If a boiler goes down, we can’t start an autoclave qualification—and production may need that equipment later the same day.” Clear communication keeps everything moving.
Who’s on your team?
“The validation function touches the entire company,” Dain Hughen says. While he and his metrology counterpart provide the core expertise, success relies on broad collaboration. Colleagues in manufacturing and QC often execute parts of qualifications after he trains them, and metrology oversees third-party vendors and scheduling to ensure work is completed without disrupting operations. “It’s a lot to coordinate,” he adds. “We manage about 1,600 active assets, so there’s a full list every month.”
How did you get into validation?
“By accident,” he laughs. Dain Hughen studied psychology at UCSD, started in glass washing, then moved into drug product manufacturing—prepping components, supervising sterilization, and supporting drug product manufacturing operations as a filling operator. After several years, he was tapped for validation. “I’d been supporting validations and enjoyed it, so I made the switch—and I’ve been in validation for about 18 years.”
“The work I do ultimately improves the lives of patients.”
What advice do you have for someone who wants to get into validation?
“It’s a great and rewarding field, but hard to break into. The best way is through operations—manufacturing, QC, or QA,” he says. Working on the front lines and volunteering to support validations builds real understanding. “You can’t be a subject matter expert in everything, so you lean on others. Hands-on experience gives you a solid foundation to jump in.”
How do you handle protocols and audits across different equipment or systems?
“When new equipment or systems come in, vendors often provide qualification protocols,” Dain Hughen says. “We add a ‘Cover Protocol’—supplemental tests and requirements we need to fulfill our qualification requirements.” His team reviews vendor protocols “with a fine-tooth comb” and design strategies that stand up to differing global regulatory expectations: “We adapt policy and qualification approaches based on historical knowledge and current trends.”
Your team has been busy with the new fill finish line. Tell us about it.
“It’s pretty exciting times- the new high throughput fill line and isolator have landed, as have the autoclave, oven, parts washer and more,” he begins before rolling on. “We are really getting into the weeds on qualification documentation, and validation activities.”
“We adapt policy and qualification approaches based on historical knowledge and current trends.”
What keeps you motivated—and what’s life outside work?
“The work I do ultimately improves the lives of patients,” he says. Much of validation is behind the scenes, but “those documents give us the confidence to make quality product and deliver it safely.” Outside work, he splits time between surfing, fishing, and snowboarding with his kids. He also has an art background (oil painting and drawing) that offers a creative counterbalance to the “rigid guidelines, requirements, policies, and procedures” of GMP life.
What do you value about Argonaut’s culture?
“It’s a respectful environment,” Dain Hughen says. “The growth we’ve had is a testament to everyone’s hard work; staying disciplined will keep us successful.”
Argonaut is a leader in pharmaceutical, combination products and IVD contract manufacturing services with over 100K square feet of manufacturing facilities. No other life science, diagnostic, or drug product contract manufacturing organization (CDMO) offers broader scale, more flexibility and faster speed to market with lower risk, and less capital expenditures.
Discover how Dain Hughen expertise can elevate your manufacturing processes—reach out to us today to learn more!
