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What Is a Validation Engineer?

What Does A Validation Engineer Do?

All validation professionals, regardless of their specific roles, follow a Validation Master Plan. This document, produced for each manufacturing site after a Validation Risk Assessment, lays out the specifics of all validation activities within the manufacturing process.

There is also a validation protocol document to be followed.

A Validation Protocol is a written plan that states how validation will be conducted including test parameters, product characteristics, production equipment and decision points on what constitutes an acceptable result.

The protocol is written for each validation process and outlines the steps and measurements required, what proof is needed, what the expected outcomes are, and what should be done if actual outcomes deviate from this.

Validation assessment can include scrutinizing selectivity, specificity, accuracy, repeatability or many other factors. Results of validation testing will be analyzed and compared to either internal or external standards.

Any deviation from this standard will require immediate corrective action. With validation testing occurring throughout the manufacturing process, the area of concern if a deviation from the standard is found, is usually quite limited.

Specific tasks can vary depending on the niche of any particular validation role. But, in general, activities can include:

  • Populating validation protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria)

  • Testing of equipment

  • Organising data

  • Analysing test results

  • Documenting and reporting the analysis of test results

  • Reviewing and maintaining technical documentation

  • Providing evidence of both internal and external regulatory compliance

  • Troubleshooting in the event of abnormal testing results

  • Troubleshooting issues identified by other staff members

  • Ensuring accurate records of all validation activities

  • Supervision of junior staff or management of a team of validation professionals

As you can see, the role can be extremely varied. There can be an interesting mix of office-based report reading and writing, and laboratory, clean room or production-line based assessments.

Skills Needed

The ideal skill set for someone moving into validation includes:

  • Strong documentation bias – you will be managing and documenting the entire validation process. The documentation produced must comply with both internal SOPs and externals regulations

  • Attention to detail – it is vital that validation engineers pay attention to every test result and measurement, noticing when something isn’t quite right

  • Analytical thinking – as well as identifying when there is an issue, part of the role can be to suggest why there might be an issue and potential fixes

  • Enthusiasm for working in a team – validation of equipment systems is a team activity and you will need good verbal and listening skills to share information amongst the team members

  • Good written communication skills – report and protocol writing is an essential part of the job

  • Preference for a structured approach to working – your work will impact others in the overall Validation team as there will be many documents that require sharing and signing with multiple team members

  • Mathematics – gathering, interpreting and reporting on numbers is a significant part of the role

  • Computer skills – there is a lot of organisation and interpretation of data required, computer skills are essential

  • Time management – there is a timeline of testing that needs to be followed

  • Initiative – validation engineers need to be able to think on their feet and come up with new and inventive ways to challenge the processes and fix problems