Validation Engineering - What's it about???


Thread Starter


I see that nowadays the demand for VALIDATION Engineers (with Electrical and Automation experience) have increased - mainly recruited by Pharmaceutical companies.

I wanted to educate myself about what are the "validation" engineers function / duties.

Where can I get courses and certification to become a VALIDATION Engineer in Canada (Toronto).

Are there already too.......many Validation Engineers in the market or there is a scarsity of them. Is the demand real???

Validation engineers are a necessity of the time. All the Biopharma projects have to be approved by the FDA. Hence while seting up facilities to manufacture drugs the validation procedures need to be followed, saving on time and cost

Anonymous Coward

A validation engineer duty is basically to validate systems: For example, If you are a validation engineer in company X, and a contractor or a designated team inside X has developed a control system, your task is to ensure the system works as written in the specifications. Once you give your aproval, the system is considered as validated and can be released to production. If a change is made to the control system (ie: a bug fix), the system could need to be validated again before it can be used in production.

This process is mandatory for all FDA regulated industries.
Product validation is necessary to verify that all contract requirements have been met by the system design - post manufacturing.

For example I could ask you to design a milk shake machine that will give me either chocolate or strawberry milkshakes but never both and only between the hours of 12 pm to 6 pm.

As a validation engineer you would be responsible for creating a test procedure that covers the functionality requirements of this system, and then produce a paper trail that shows that the sytstem has been tested (validated) and have repeatable and accurate data to show for it. If you work for an ISO company then you will be chained to your desk most of the time (like me :))