Validation Opportunities

Validation Opportunities command the highest salary levels in the pharmaceutical / biotechnical / API / medical device, industries, and yet does not demand the highest level of academic achievement. The emphasis is more on the side of experience and practicality. Browse through these attached job vacancies and you can see where the emphasis on candidate suitability is place. These are typical of the multitude of validation opportunities that abound, in as much as the advertiser is not laying down a demand for wall to wall qualifications, but is stipulating an in depth knowledge of validation as a requisite for the vacancy.
This is quite the norm for the industry. Had the vacancy been for the laboratory or process side of the business, the salary offered would command at least a PHD level of qualification.
Validation started in the aircraft industry back in the 1950’s, it came about simply because of the atrocious reliability of the then current aircraft. Liability law was growing exponentially and people in the aircraft industry suddenly realized that one accident was unique, two accidents was improper, use or manufacture. QA was born, every manufacturing process was documented. The process was then validated, all parts of the process were calibrated, validated and verified. Nothing could be used that was not a known item with certification of its component parts and final specification. Every company had to write a Company Exposition, which was a precursor to an ISO Quality Management Procedure.
Quality was inspected into every process from the mining of the basic ores to the painting of finished aircraft, everything carried release certification. No release certification, certificate, and the item could never be used.
Passengers killed, started to fall, aircraft lost, started to fall. Now every single thing that went wrong was subjected to detailed investigation (at times regardless of cost). There was no place to hide skeletons, if mistakes had been made during production or operation they were made public. Companies closed or conformed.
The pharmaceutical industry never went through this stage and have never come close to the degree of quality control that is standard practice in the aviation industry. This is why there is still a great call for validation staff and validation opportunities abound. The industry is far from being properly under control. The Comet disasters in the 1960’s shook up the entire aircraft industry when around 200 people were killed. The Thalidomide disaster around the same time caused severe malformities to 10,000 infants, and resulted in a call for further tests in future, but no call for more exacting manufacturing procedures.

In a NO BLAME CULTURE environment, when a serious problem occurs the first assumption is that the person concerned is innocent and that a system failure has occurred. An investigation is carried out with a view to finding a rational explanation for the problem. If, in deed, this results in a system failure being identified, it is corrected and steps are taken to ensure it is not replicated. If a person is found to be at fault then corrective steps must be taken to prevent a re-occurrence. This is where the tough decisions have to be taken. The FDA is quite adamant that certain types of offences must lead to dismissal. In the aircraft industry any action which jeopardizes quality or safety is a sacking offence, this has been learned the hard way and is generally not negotiable. The pharmaceutical industries must follow suit. The NBC cultures I personally have experienced in the industry will collapse completely, when the first disaster occurs, and senior management suddenly realizes that further down the ranks they are operating a cosy NBC. It is an excuse for inept supervision and management.