Validation engineers are an integral part of the operation and manufacturing process of any pharmaceutical, biotechnology and medical device company. They carry out crucial functions to ensure that drugs and treatments are safely and effectively produced for patients all over the world. Validation engineer jobs are on the rise and always in demand, so take some time to explore if becoming a validation engineer could be the right career for you, and how to find a way in.
What is a validation engineer?
In the life sciences industry, validation engineers evaluate, test and maintain equipment used by companies to develop, manufacture and dispense drugs and treatments. In short, they make sure that everything works how it should be running quality tests. There are validation engineer job opportunities across the entire industry including pharmaceutical, biotechnology and medical devices companies.
Validation engineer is an umbrella term for a group of engineers who specialise in different types of quality control. For example, a computerised system validation (CSV) engineer is responsible for ensuring computer systems work as they should. Other examples include process engineer, automation engineer and validation analysts, who focus more on scientific aspects.
What are the responsibilities of a validation engineer?
The principle responsibility of validation engineers is testing equipment, computer systems, methodology and processes. Day-to-day, they create reports and adjust equipment or processes that need to be improved or repaired. To ensure that what they are testing meets standards, validation engineers carry out the following responsibilities:
- Establish validation standards
- Develop testing protocols
- Test equipment and maintain records for later analysis
- Document and report the analysis of tests
One of their most significant duties is writing protocols. This requires in-depth knowledge of the product or equipment so that they can gauge what the necessary output is and if it meets the pre-defined criteria.
What is the demand for validation engineers?
As the job role of a validation engineer requires a very niche skillset, demand for this career path will always be high. Every pharmaceutical company will need to employ skilled validation engineers across the board as every aspect of their development and manufacturing processes will need to be quality checked against regulations. This high demands opensup many opportunities for validation engineers who can choose to become contractors, working on short-term projects on high hourly rates.
There is the option to work on a remediation project as a contract validation engineer. This is a popular choice for many as opportunities are plentiful. Being contracted for a remediation project involves being sent to a company to help to resolve a quality issue, often in manufacturing, quickly and effectively to help them to pass health authority audits by regulatory bodies.
What qualifications/training do I need to get a validation engineer job?
Validation engineer jobs require being educated to degree level in a subject such as electrical or mechanical engineering or computer science, depending on the field of validation they wish to go into. Good mechanical understanding is also needed so that the quality engineers are able to understand laboratory equipment and processes.
How do I get the right experience for validation engineer jobs?
The key to successfully moving into the life science industry is to gain some solid experience within a regulated industry before applying for a quality role at a pharmaceutical or medical devices company. Often, a generalist engineer will work on a project within this field and then choose to specialise and become a validation/quality engineer.
Validation engineers come from various different engineering disciplines including automation, mechanical and chemical. As long as relevant educational background is paired with a quality mindset, they will have all the tools they need to be successful as a validation engineer.
What are the different career directions you can take as a validation engineer?
Candidate A has been working as a process validation engineer for several years. There is a clear cut path ahead with various stages of progression, usually around four. Eventually, Candidate A aims to move into a management position.
Perhaps the most popular career path for validation engineers is to become a subject matter expert (SME). Candidate B has worked as a CSV engineer for many years and would like to use their expertise to develop their career. They prefer the idea of working on short-term (6 month) projects, while getting paid high hourly rates for their expertise. This is essentially a freelance position, and Candidate B is interested in using this freedom to work internationally.If you would like to have a look at our current permanent and contract validation engineer jobs, please visit our job board to see all opportunities in validation.