Five minutes with…Melanie Feichter.

My route into engineering started with a degree in biotechnology, but my career has evolved quite naturally over time. I joined BakerHicks in Vienna almost six years ago as a Senior Process Engineer, having previously worked for other engineering consultancies.

Right from the beginning, I was involved in Fill & Finish projects. In many ways, one project tends to lead to the next. You start by supporting smaller or specific technical activities, then move into concept design, basic design and eventually full execution projects. Along the way, the scope of responsibility gradually expands as does your experience in dealing with a wide range of project challenges.

For me, the transition into project management wasn’t a single career move or a deliberate change of direction. It happened organically through a series of projects, each bringing a broader perspective and new challenges. Today, I lead the Project Delivery department in Austria, but I still remain closely connected to the engineering side of the business.

That connection is important to me. Fill & Finish, and filling in particular, is where my passion has always been. Whenever there’s an opportunity to work on an interesting filling line project, I’m still keen to get involved.

Filling is essentially where everything comes together. You can develop an excellent product and have a highly efficient manufacturing process, but if something goes wrong during filling, there can be an immediate impact on quality and, ultimately, patient safety. That’s why I often describe filling as the heart of the pharmaceutical production chain.

This is the stage where a product is transferred into its final primary packaging, whether that’s a vial, syringe, cartridge or another container. By its nature, it’s one of the most sensitive parts of the entire process. The product is often exposed to its environment and the requirements for sterility and quality are exceptionally high.

As a result, the regulatory framework is extensive, particularly with Annex 1 and other GMP requirements. What I find particularly interesting, however, is that while the regulations are very clear about the outcomes that need to be achieved, they don’t prescribe every detail of how you get there.

That leaves room for engineering judgement. It requires a combination of technical understanding, regulatory knowledge and practical problem-solving. It’s that balance between precision and creativity that continues to make Fill & Finish such an engaging area to work in.

One of the biggest changes has been the need for greater flexibility.

In the past, facilities were often designed around a single product that would remain in production for many years. Today, the environment is very different. Products change more frequently, batch sizes are becoming smaller, and therapies are increasingly tailored to specific patient groups.

This is particularly noticeable in contract manufacturing. A facility may be producing one product today, a different product tomorrow and another with entirely different requirements a few years later. The challenge is creating a facility that can adapt as those demands evolve.

That’s why flexibility, if not modular design, has become such an important design principle. A filling line should be able to accommodate different packaging formats, such as vials, syringes and cartridges. Layouts need to allow for future modifications, equipment replacement and process changes without disruption to operations.

It’s not just a question of physical space, though. We’re also seeing significant technological change. The pharmaceutical industry tends to favour proven solutions – understandably so – because patient safety is paramount. At the same time, changes to regulations and industry expectations are driving innovation, particularly where interventions can be reduced and processes made more robust.

As a result, we’re seeing greater adoption of technologies such as single-use systems, advanced automation, isolators and robotic solutions. These approaches can reduce human intervention, improve consistency and support compliance with increasingly demanding regulatory requirements.

Ultimately, facilities are now being designed with a much longer-term perspective. Success is no longer about delivering a plant that works for a single product today; it’s about creating one that can continue to evolve throughout its entire lifecycle.

One of the biggest advantages of coming from a process engineering background is that it gives you a clear understanding of what the facility is ultimately there to do. We’re not designing buildings for their own sake; we’re designing environments that enable complex manufacturing processes to operate successfully.

When you understand the process, you gain a better appreciation of many of the factors that drive a project – requirements, equipment interfaces, procurement timelines, qualification activities and operational challenges. It helps you see how the various pieces fit together.

It’s also influenced how I work with project teams. Having worked as an engineer, I understand the importance of ownership and accountability. People are most engaged when they know what they’re responsible for and how their contribution supports the wider project.

Like all good project managers, that’s why I place a strong emphasis on clear responsibilities. Rather than simply distributing tasks day by day, I believe people should understand their role within the bigger picture and the outcomes they’re ultimately responsible for delivering. It creates clarity, improves collaboration and gives teams a greater sense of purpose.

Even now, I still enjoy staying involved in the technical side of projects, whether that’s developing URS documentation for filling lines or supporting qualification activities. At the same time, I recognise that successful projects rely on specialist expertise across many disciplines.

For me, the ideal balance is to remain close enough to the engineering to ask the right questions, while trusting the expertise of the people around me. That combination of technical understanding and collaborative leadership is what allows projects to perform at their best.