What Is Validation?
Validation describes the process of creating an evidence trail to show that an action, process or system leads to a consistent and reproducible result. This ‘result’ is typically either taking a measurement or assessing product quality.
Validation is a central part of the manufacturing process within the pharmaceutical and medical device industries. The products made must be exactly the same every time and are tested at the end of the production process to ensure that this is the case but final end product testing isn’t enough.
In addition, the processes, systems and equipment that lead to their manufacture are closely scrutinised too. This establishes that they meet predetermined specifications and always produce the same result. Each step in the manufacturing process is subject to validation, to ensure that the end products are safe and effective, every time.
Validation tasks are carried out during all stages of a product life cycle – from research and development, through to manufacture and distribution. Validation is not only important in the establishment of manufacturing protocols but it is also used to make that changes to systems, equipment or processes within an established manufacturing system, do not change the outcome or product.
What Does A Validation Engineer Do?
Even within pharmaceutical and medical device manufacturing, there are several types of validation roles. Examples include Process Validation, Cleaning Validation, Computer Systems Validation and Equipment Validation. Each of these roles focuses on a different part of the manufacturing pathway and serves as a validation specialty.
Other roles such as Qualification and Verification positions are closely related to Validation. Verification focuses on whether systems and processes are meeting predefined specifications, validation is concerned with whether the output of that system or process is consistent and reliably meeting the needs of the user.
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. 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 scrutinising selectivity, specificity, accuracy, repeatability or many other factors. Results of validation testing will be analysed 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 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:
- Writing of 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
- Review and maintenance of 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.
For a great insight into validation roles from someone actually in the job, check out this video from the About Bioscience website, produced by the North Carolina Association for Biomedical Research (NCABR).
Becoming A Validation Engineer
There is currently an acute shortage of validation skills in the industry so it could be a great time to consider a mid-career change into validation. This is especially true in the Republic of Ireland. If you want to see more about the number and kinds of jobs that are available, check out our jobs boards for Ireland, the UK and Philadelphia, USA, and select Validation or Validation Projects from the “Jobs by Category” menu.
To become a validation professional, a Bachelor’s degree (usually in science or engineering, or something similar) is the typical requirement. A lower level qualification with accompanying work experience can be a realistic alternative though.
On top of this level of education, a candidate needs to be able to demonstrate familiarity with regulatory guidelines and industry standards.
The ideal skill set for someone moving into validation includes:
- Attention to detail – it is vital that validation engineers pay attention to every test result and measurement and notice 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, as well as potential fixes
- Team working – these professionals can be working with people throughout the manufacturing process
- Good written communication skills – report and protocol writing is an essential part of the job
- Organisation skills – protocols and timelines have to be strictly followed
- 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