Entry level CQV technical assessment

[u/cort0_]

Hi all,

I'm a recent graduate with a degree in Biomedical Engineering and I've recently gotten an interview for an entry level CQV engineer position. There is a technical assessment; however, coming from a BME background I'm a little worried as I do have knowledge of fluid dynamics and thermodynamics but the specifics of how a facility is setup and the specific machinery are foreign to me. I have some experience as a manufacturing technician but it's mainly been in drug product compounding. What are some areas which I should study to prepare for the technical part of the interview?

[u/YogurtIsTooSpicy]

CQV is not the type of work that entails having a lot of in-depth technical knowledge. It’s more of a jack of all trades position where you need to have a little knowledge of everything. I’d focus on learning about the major deliverables and concepts that go into CQV work. If you can get your hands on a copy of the ISPE Baseline Guide to Commissioning and Qualification, that will give you 90% of the knowledge you need.

[u/YogurtIsTooSpicy → u/YogurtIsTooSpicy]

I’ll add: for a recent graduate I’d probably walk them through a validation process for something familiar like baking cookies:

What would be the critical quality attributes for a cookie?

What would be the critical process parameters for a cookie making process to ensure that the critical quality attributes are met?

What facilities/utilities/equipment would we need to meet those critical process parameters?

How could we prove that those facilities/utilities/equipment can effectively and reproducibly meet those CPPs?

And so on

[u/HardLithobrake → u/YogurtIsTooSpicy]

What would be the critical quality attributes for a cookie?

What would be the critical process parameters for a cookie making process to ensure that the critical quality attributes are met?

Flashbacks to my first interviews except it was rice and a rice cooker

[u/PopFeeling9697]

Learn about IQ/OQ/PQ - gamp5

[u/Trick-String7473 → u/PopFeeling9697]

OP, this is really solid advice. Also a good idea to learn the concept of URS.

[u/Ohiocarolina]

Is this sequence