What is a Validation Engineer?

One of the most in-demand jobs in Ireland at the moment is Validation Engineering. The demand for this engineering specialty is driven by the strong pharmaceutical and medical device manufacturing industries that are in the country. Modern regulations both here in Europe, in the US, and elsewhere in the world mean Validation Engineers are crucial to the success of these industries.

Before looking at what a Validation Engineer does, however, let’s first look at validation.

What is Validation?

Manufacturing processes are designed to produce a product or item to a specific level of quality. In highly regulated industries like pharmaceutical manufacturing, this level of quality will be very high.

However, manufacturing processes are not static. Temperatures change, raw materials can vary, machine parts deteriorate, etc. Therefore, it is not enough to simply design a process and then continue to use it without further monitoring. This is especially important in the manufacture of medicines and medical device products.

This is where validation becomes so important. Validation is a process that ensures the consistent quality of items produced by providing documented evidence that the equipment or process producing these items performs as per specification.

However, validation is much more than simply testing items as they roll off the end of a production line. Instead, validation involves closely scrutinising and documenting every stage of the manufacturing process. This includes checking the process itself, checking the systems that run the manufacturing process, and checking the physical equipment.

Using this validation process, Validation Engineers can quickly identify problems. Crucially, they can also quickly identify the main cause and source of a problem. This makes correcting the issue much more efficient.

Therefore, validation minimises machine downtime, helps to prevent sub-standard products going into distribution channels, improves productivity, and makes it easier to ensure full regulatory compliance.

Entire Product Lifecycle

While validation is crucial to the production of live, salable products, it is, in fact, a requirement throughout the entire product lifecycle.

In other words, validation begins with the research and development phase, i.e. before the product goes into full manufacturing. Validation is also required when designing a new manufacturing process, plus it plays a role in packaging, distribution, and more.

Responsibilities of a Validation Engineer

Typically, Validation Engineers work in industries that are highly regulated. As already mentioned, pharmaceutical manufacturing and medical device manufacturing are two examples that have specific relevance in Ireland.

In general, a Validation Engineer is responsible for the validation strategy of a company including the planning, implementation, and monitoring of that strategy.

Therefore, the responsibilities include:

  • Measuring and analysing manufacturing processes
  • Analysing test results
  • Auditing and calibrating equipment
  • Testing equipment
  • Creating and maintaining accurate data on the above
  • Preparing and presenting reports
  • Providing evidence of regulatory compliance
  • Liaising with regulators

Ultimately, the goal of a Validation Engineer is to ensure the manufacture of products or items to a consistent level of quality. That level of quality must be within pre-set tolerance levels. In addition, a Validation Engineer must ensure full regulatory compliance.

Key Skills of Validation Engineers

  • Strong documentation and record-keeping skills
  • Analytical thinking
  • Attention to detail and a structured approach to working
  • Good communication skills
  • Mathematics and computer skills
  • Flexibility and adaptability
  • Time management skills and the ability to work on your own initiative
  • Problem-solving skills

Becoming a Validation Engineer

Entry to a career as a Validation Engineer is typically via an engineering bachelor’s degree. Specifically, Validation Engineers often originally graduate with electrical, software or mechanical engineering degrees.

Most roles will also require experience, so a key step is to begin working for a company that has validation requirements.

Once in a Validation Engineering role, you will find it is a rewarding and interesting career with strong growth and development prospects and opportunities.

Dermot McMorrow

Dermot is SL Controls' Compliance Director. He is responsible for the company's quality management systems and maintaining high compliance standards. Dermot is a validation specialist and has extensive experience leading validation projects for clients in Ireland and internationally, particularly in the multinational pharmaceutical and medical device sectors.

View all posts by Dermot McMorrow