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validation protocols

2007-03-01 22:08:02 · 6 answers · asked by hughbtwo 1 in Science & Mathematics Engineering

6 answers

Career Overview
A highly technical position, the validation engineer completes or oversees all the calibration and testing of the various instruments and pieces of equipment used in the lab for measuring, weighing and processing raw and refined materials.

The validation engineer is usually responsible for determining what equipment in the lab needs to be replaced or removed, and also may be responsible for completing the laboratory equipment budget, purchasing new equipment and even training others on the team in the proper use of the equipment. The validation engineer often works directly with contractors, suppliers and vendors to troubleshoot or install equipment with the lab or manufacturing plant.

The validation engineer is usually the team leader or supervisory for the validation technicians and lab employees. He or she may also be directly involved in the training and mentoring of new employees and team members with regards to equipment use and calibration. The validation engineer should have excellent communication skills, be a problem solver, and have good understanding of good laboratory practices (GLP) and good manufacturing practices (GMP).

The validation engineer should be well versed in proper documentation and data analysis as well as be an independent worker and able to meet reporting deadlines and guidelines.




Career Requirements
The minimum level of education for a validation engineer is a Bachelors degree in a science field and several years experience in the field of validation. Many validation technicians work towards their Bachelors or Masters degrees while employed by a lab so that upon graduation they have both their degree and work experience.

Depending on the type of equipment and facility the validation engineer should have a good mechanical understanding of laboratory equipment as well as a background in computers. Additional certification for calibration of equipment is often considered critical. Some pharmaceutical and biotechnology companies require additional training in Aseptic Processing Guidelines as well as GLP and GMP training. ♥

2007-03-01 22:12:53 · answer #1 · answered by St♥rmy Skye 6 · 0 2

This is simple: I'm going to start telling you WHY and then WHAT.

Why do a company needs Validation Engineers (VE)?.

Validation is a way of providing statistical data than something is good for the intended use. You don't just buy a machine and put it in production, you need to assure the company, the client, regulated agencies, etc that this new machine, new process, new product etc, is capable of doing what I say on paper that it was going to do.

What is a common or more steps in a validation? For example we are going to make a new screw.

1- I need to design the screw and say that the screw is capable of resisting I dont know how many PSI.
2- Before you buy the machinery to make the screw, you need to talk with the supplier. The VE create the requirements (FRS, URS etc). Those are written and as you know, the paper can say whatever I can put in it.
3- The VE can make some testing before accepting this machine or he can do it on site (FAT or SAT).
4- You bough it, now you have it on-site, now you need to do IQ/OQ/PQ
IQ= Installation Qualification is for making sure the Power, Air Pressure, Leveling, Safety, etc are according with the manual and manufacturer specs.
OQ= Operational Qualification is for testing that the machine can run and make the screw in accordance with my design. In some cases they test the limits, (Example, the screw can range 1.000 +/- .1 of length sot they run the machine at .9000 and at 1.100 to see if the machine is capable of keeping the length in my limits.
PQ= Process Qualification is for test the "Nominal" measure of 1.000 and see how much variance is in the process. In this step, thy also include all of the process as an operator would do it. They have an Standard Operating Procedure to follow etc.

All of these runs or tests need to be calculated using Sampling Plans that can say if the machine or process is capable of making good units. These are based on the VE criteria (also management).

Here you can use simple statistical data like sampling plans with AQL with acceptance, reject and more complex using software like Minitab.

In other words the VE is the one that say how he is going to prove using Numbers that something is good to go.

Hope this works

2016-02-23 02:20:11 · answer #2 · answered by omar 1 · 0 0

If you meant in software engineering, validation is one level higher than verification. Verification makes sure a design does exactly what its designer wanted it to do: that is mostly code-level testing. Validation, in turn, makes sure that what a designer wanted the code to do really solve the customer's problem: that is a validation engineer is a rear-end systems engineer who makes sure the completed software is what the customer expected.

2007-03-01 22:25:01 · answer #3 · answered by sciquest 4 · 0 1

Are you asking about the Validation ENGINE that you can get for FREE from Microsoft? If you are, here's the URL:

2007-03-01 22:13:49 · answer #4 · answered by Wizard of Oz 3 · 0 4

First, verify in case your college is approved by technique of ABET in that way you are able to discover in case your degree is valid on the u . s .. 2d (and in case your call is approved by technique of ABET) in case you want to be approved contained in the u . s . you want to previous the EIT and PE.

2016-12-05 03:32:52 · answer #5 · answered by boshell 4 · 0 0

glorified testing engineers

2007-03-01 22:15:51 · answer #6 · answered by Anonymous · 0 4

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