Validation Engineer

What does a Validation Engineer do?

Validation engineers monitor systems, equipment and processes used in pharmaceutical contexts, especially in manufacturing. They may work in collaboration with process or CSV engineers, scientists or QA specialists. This involves managing, analysing, inspecting, calibrating and testing – and sometimes modifying or improving – everything that ensures that the company’s products meet the agreed specifications and comply with safety and quality regulations.

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What roles and responsibilities can you expect as a Validation Engineer?

A Validation Engineer may be part of a larger team where responsibilities are split between team members, or in a smaller organisation where the role is broader. Roughly speaking, responsibilities fall into three groups – monitoring and testing, reporting and documentation, and training / supervision.
As examples, responsibilities may include some or all of the following.

Monitoring and testing:

• Testing the proper functioning of equipment and resolving any issues, including making adjustments or improvements;
• Maintaining the correct calibration and other parameters of instrumentation and equipment;
• Correctly interpreting customer requirements, and initiating and supervising validation activities.

Reporting and documentation:

• Creating databases and validation schedules to track validation activities;
• Documenting test results and performing analyses;
• Preparing compliance, analysis and other reports.

Training and supervision:

• Training and updating staff in your team;
• Overseeing the work of junior team members;
• Regularly updating knowledge of industry standards and regulations.

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What education and skills do you need as a Validation Engineer?

It is possible to move into a Validation Engineer role as a school leaver, but generally you will need a degree in a relevant engineering discipline and previous experience in a Validation Engineer or similar role however junior, perhaps as a student, will give you a head start.

Specific skills and attributes you will need typically include:

• A detailed understanding of manufacturing processes and the appropriate safety regulations;
• Knowledge of statistical software analysis using systems such as MATLAB;
• The ability to find effective solutions to complex problems using analytical thinking and a methodical approach;
• Excellent mathematical skills and attention to detail;
• Good organization and time management.

What salary can you expect as a Validation Engineer?

Your salary as a Validation Engineer depends on the level you join at (linked to qualifications and experience) and the specific role, but in the Netherlands you can expect around €51.900,- – €77.800,- per annum. With more experience, you might move up to a more senior role such as Validation Lead or Project Lead.

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