Colleague in the Spotlight – Brent

Brent is one of our junior consultants. With three years of validation experience in GMP production environments, he has a lot of practical and theoretical knowledge about cleaning validation and sterilization validation.

In this short interview, we let Brent talk about the content of his duties as a validation consultant.

What are your main tasks as a validation consultant?

My tasks are very diverse and in fact almost every task within the validation life cycle is equally important. As soon as one task is not or insufficiently performed, this can cause problems during an audit. What always has priority is safety. This is especially important during a tank entry. For example, when I have to swab the inside of a 10 000L bioreactor, strict safety regulations must be followed. On the one hand, I must check that the system cannot be operational when I enter the tank, and on the other hand, I must also wear the necessary PPE (harness, helmet, Tyvec suit, etc.).

What do you like about this assignment?

As a validation consultant at a pharmaceutical GMP manufacturing company, I have an enormously varied job that makes almost every day look different. Furthermore, at the start of my project this allowed me to learn an enormous amount in a short period of time. I am currently doing a combination of cleaning validation, sterilization validation and engineering. I spend a significant part of my time writing validation documents, but a large part of my time is spent in clean rooms and technical areas taking swab samples, placing thermocouples (incl. tank entry), checking technical installations, etc.

There must be disadvantages to the job too?

When a new installation is ordered, validation is the last step that needs to be done before the installation can be put into operation. Depending on the size of the project, deadlines are set months or even years in advance. If delays occur before the start of the validation phase, a lot of pressure can be put on validation engineers to get everything done by the deadline. So a certain amount of stress resistance is definitely a requirement within validation.

You started three years ago as a young graduate in Life Sciences. Why would you recommend this sector to recent graduates?

When I graduated with a master’s degree in biomedical sciences, I didn’t know exactly which job to choose to apply for. The pharmaceutical industry did appeal to me, but what exactly I wanted to do there, I didn’t know. As a consultant you have the advantage that you will be working on projects, so there is more variety, and you can choose more often or faster to give your career a different direction (e.g. do more or less tests yourself, other types of validations, or take a completely different path within Life Sciences).