A Validation Team Member is a type of validation professional based within an engineering consultancy, not within a pharmaceutical or medical device manufacturing company.
People in this role will typically work within a project team on large, capital projects. This type of validation role can bring a higher salary than Validation Technicians as there is often a lot of overtime associated with it. It is also common for people to have to move to where the job is located or work away from home for a significant time.
This specific validation role will have a strong focus on commissioning and qualification of equipment and equipment systems. When the project validation is complete, ongoing validation responsibilities are handed off to in-house Validation Technicians and the consultancy will move the Validation Team Member to work on the next project.
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 scrutinized too. This establishes that they meet predetermined specifications and always produce the same result.
A Validation Team Member will work on the initial commissioning and qualification of equipment and equipment systems to ensure they are installed correctly and are fit for purpose. This still involves a large amount of documentation. The consultancy-based validation team will then typically “hand over” to an in-house Validation Technician for process qualification.
The specific tasks required by an individual will vary depending on the project. Examples of tasks could include:
- Populate validation protocols
- Commissioning and qualification of equipment and equipment systems
- Perform IQ OQ PQ Installation Qualification, Operational Qualification and Performance Qualification) of equipment, instruments and piping systems, along with automation controls and building facilities
- Developing new validation documentation
- Collection, organization, and documentation of test data
- Completing validation documentation
- Investigating abnormal testing results
- Troubleshooting validation problems
- Ensuring accurate records of all validation activities
- Participation in internal audits and external inspections as required
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.
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.
The ideal skill set for someone moving into validation includes:
- Strong Documentation Bias – as you will be managing and documenting the entire validation process
- Attention to detail – it is vital that validation team members follow validation protocols precisely to ensure that the results are reliable
- 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
- 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
- Good communication skills – Must be able to take and understand instruction well, putting them into action quickly and effectively
- Mathematics – gathering, interpreting and reporting on numbers is a significant part of the role
- Computer skills – there is a lot of organization and interpretation of data required, computer skills are essential
A typical career path would be to start in an entry level position within a Validation Team. As you build up experience and are given more responsibility, you will move up in seniority within the team. The most senior positions are Head of Validation roles where your responsibilities would evolve to planning the overall validation strategy, developing the Validation Master Plan and managing the team.