An Insite to the world of Validation.
The Validation Academy can open opportunities that 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 opportunities that the Validation Academy can make accessable
to your paticular skill set. The situation vacant, 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,
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
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
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
Validation Academy was formed to introduce skilled qualified people to the additional skills that the day to day operation of validation requirements demands. As consultants just about everywhere we go we are asked by all levels and skills of staff if there is a course that can be taken that will give
you the validation skills set. It is the intension that the Validation Academy will slowly introduce such a
Can you prove these validation salaries?
We could, but
the best way to convince yourself is to ring the agencies that are advertising
validation vacancies. A biologist with a basic degree or who starts in a
laboratory straight from school (with A levels) can expect to earn £16/19K,
(€23/27K), ($27/33K) per year, in a permanent position. In a contract position
around £10/14/hour, (€14/20/hour), ($17/24/hour). With Validation Academy Training Center, training they would immediately jump to £24/28/hour,
(€35/41/hour), ($41/48/hour), quite substantial extra income. After one years
field experience they could earn an easy £32/36/hour, (€46/52/hour),
($55/62/hour). After that it really depends on equipment experience, if a
company wants specialized people then they have to, and do, pay the going rate. The same applies to
persons who enter the validation field from an engineering background
(mechanical / electrical / instrument / electronic / software / IT). Fitters
with a few years experience are ideal training
Why such high rates?
Validation is all about experience and know how. When
pharmaceutical companies start, move, alter, modify in any way, equipment (all
equipment) that is used to produce their product, then the regulators (FDA, HMRA
etc) demand, and will inspect to ensure, that all the equipment has been
revalidated. This is time consuming and expensive for the companies, but no
exceptions are given.
When a new plant is being built and approaching the production stage it often soaks up every contract validation
engineer available in that area and sometimes in the surrounding countries. This
has been the norm for many years and was vividly demonstrated in the early 2000's; in the explosive growth in, pharmaceutical manufacturing, in Ireland, which drew in validation staff from all over the world.
Validation Plan (Issue 10) - $ 93.00
The Validation Plan (VP), is the starting point for any validation task, and the most important validation document. It greatly improves validation efficiency by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is a mandated document with regulators and auditors.
While in the past validation was more focused on functions of procedures,
recently the focus has progressed into infrastructure, networked systems and on
security, authenticity and integrity of data acquired and evaluated by systems.
User Requirements Specification (Issue 8) --
This document was designed to be used as a live document up until the DQ
is completed and approved. It uses three
levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee
traceability from the URS through to the final PQ and OQ functionality
testing. A mandatory requirement for
Full Life Cycle Validation of computer systems that are the subject of predicate
rules. It can be used on mechanical,
electrical and software controlled, monitored or driven systems.
Assessment (Issue 11) -- $125.00
This is a robust and
simple to execute document, one that will lead you through the process and
deliver a result that can be used as the foundation for your validation
activities. The VRA now includes the assessment table for categorizing and
documenting the new 21 CFR Part 11 guidance
ruling on what predicate data must be stored in a Part compliant system, along
with the new broadsheet to establish your new database of part 11 records. (now
Design Qualification (Issue 5) -- $115.00
Standard Operating Procedure attached to this generic design qualification
protocol, will chapter by chapter, take you through the task of raising a fully
detailed document. The main body is split into fourteen tables, each one
probing the design requirements and standards for the individual requirement.
Safety and security along with user operability are very detailed. The document
will lead you through all these design aspects allowing you to delete some you
feel are not important to your equipment. It is an easy document to use and
will ensure that you’re DQ’s are relevant, up to date and easy to execute.
Practically all the requirements are in table form. Allowing fast and clearly
presented results to be obtained.
Validation Plan (Issue 10) -- $93.00
(Issue 9.) -- $115.00