Job Title: Senior Validation Engineer
Type of Company: I work for the oldest chartered engineering firm in North America. My division builds bio-tech and pharmaceutical manufacturing facilities that are used to manufacture drugs.
Education: BA, Mechanical Engineering
Previous Experience: I have been doing validation in the bio-technology industry for the past 15 years. Before that I worked in the same industry as an instrument specialist and a manufacturing operator.
Job Tasks: My company builds bio-tech and pharmaceutical manufacturing facilities. I primarily work starting up the equipment after is has been constructed, but usually get involved early in the project planning how the equipment and facility will be commissioned and qualified. After the planning is completed I usually work in the design phase as a process engineer in order to help the vendors understand what is expected of them when they build the equipment that we have designed. This involves multiple trips to various vendors all over the world. A good example of one of them is the Paul Mueller Co. in Springfield, MO. It is a steel fabrication plant that makes a lot of stainless steel tanks (vessels) for my company. It is one of the biggest in the world with a footprint of 1,000,000 square feet.
Once the equipment has been built or fabricated, we travel to the plant and perform acceptance tests on the equipment and verify that the equipment is acceptable and can be shipped to the plant or facility being built. After the equipment has been installed in the facility, the start-up and commissioning of the equipment begins. This process serves to start the equipment in a manner that does not damage it, since, in most cases, the equipment has not been run or operated yet. This process normally takes a team of qualified people including mechanics, electricians, process engineers, instrument engineers, etc. The equipment is then "commissioned," or tested in a way that fits the specifications that the equipment was built to. And in most cases the results are documented in some form so that the data and testing can be referenced at a later date.
When the equipment has been fully commissioned, the next step is to qualify or "validate" the equipment. Most equipment used in the manufacture of drugs for humans has to be validated, meaning that specific tests taken from specifications have been documented in the company's Quality Control format and approved by the plant's owners. These documents are normally called "protocols" for the installation, operation and performance of the equipment. Validation is almost always the last step before manufacturing can begin. When the protocols have been executed and approved, the equipment is released to the manufacturing people and production can get under way.
Best and Worst Parts of the Job: The best part of my job is the fact that we build plants that manufacture drugs that save people's lives. Some of the drugs are made for only a small part of the world's population. If they were not produced there would be no other way for some people to live normal lives. One of the plants we built manufactured a drug that had just three patients in South America with a very rare disease. So that is what I like.
Job Tips: My main piece of advice is to get involved with all disciplines if possible. During my career I have done design work, computer systems and validation. This allows you to be more billable or valuable to the job for a longer period of time. You will be able to understand and see the big picture more easily, which in the end can lead to some sort of management position.
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