A Validation Engineer in the pharmaceutical industry plays an important role. They ensure that the document process and equipment is what they say they are. A lot of this requires writing procedures, examining these documents, and compiling test data. In the industry, this process are called IQs, OQs, and PQs and the Validation Engineer manages these. Depending on the company, the Validation Engineers may report to a Director of Validation, Director of Quality, or Director of Technical Services.
IQ – Installation Qualification
IQ is the installation documentation (a report) that the physical article has been delivered, installed, and configured according to the Manufacturer’s standards or by an approved checklist. This physical article can be an instrument, a skid, or piece of a skid, like a final filter.
This IQ would detail location, orientation, utility requirements, software versions, and other things. This is to fully check that this physical article is what the manufacturer says it is. The Validation Engineer would be checking serial numbers, model numbers, and specifications.
OQ – Operational Qualification
OQ is completed after the IQ. This involves testing the physical article to ensure it performs as specified within the ranges as listed by the manufacturer. This tests each individual article.
For example, for a wide range walk in room that the manufacturer says it can go from 2C to 40C, the Validation Engineer would test this and verify that it can indeed go from 2C to 40C. At this point, the process of how it is actually to be used is not applied.
PQ – Performance Qualification
PQ is the all-in report that fully qualifies the physical article for the intended purpose. It documents that the user requirements for the physical article is met and is reproducible. This typically means the Validation Engineer is in the field observing or even conducting the testing.
This process is well described in the ISPE Baseline Guide for Commissioning & Qualification.
What else does a Validation Engineer Do?
These reports need to revisited every so often due to major corrective work done, process improvements, or change controls involving these physical articles. Validation Engineers are especially needed when the manufacturing site needs qualification or requalification by the FDA or EU (What’s the FDA of Europe?).
Validation Engineers are the critical to ensure pharmaceuticals keep people safe. Their rigorous documentation at installation, startup, and frequently during the continuous process verification (CPV) is the company’s defense against audits and ensures the everything was designed in a cGMP manner.