What is a Validation Technician?

A Validation Technician works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result. This ensures that the product is consistently of the highest quality.

• CQV Specialist
• C&Q Specialist
• Associate QA Validation Specialist
• C&Q Junior Project Manager
• Equipment & Process Validation Specialist
• QA Validation Associate
• QA Validation Specialist
• Validation & Technical Standards Specialist
• Validation Analyst – Qualification section
• Validation Specialist

And if you are interested in retraining for this position, check out our Equipment Validation Training Course for starter validation, CQV and C&Q roles.

Validation creates a documented evidence trail (through rigorously checking and testing) to show that a system, procedure or process used in the production and testing of the pharmaceutical product:

• maintains compliance at all stages
• and leads to a consistent and reproducible result

There are many other definitions of validation but the essence of all these definitions seems to be “documented scientific proof of consistent performance“.

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.

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 lifecycle – from research and development, through to manufacture and distribution and is also used to make sure that changes to systems, equipment or processes within an established manufacturing system, do not change the outcome or product.

Check out this article for a much more detailed look at validation in the pharmaceutical industry (with lots of baking analogies to make it easier to understand!)

Working within the larger validation team, and typically under the management of a Validation Engineer, a Validation Technician can have a broad range of duties.

The specific tasks required by an individual will vary depending on the role and how big the validation team is. Examples of tasks could include:

• Populate equipment validation protocols
• Commissioning and qualification of equipment and equipment systems
• Perform IQ OQ PQ of equipment, instruments and piping systems, along with automation controls and building facilities
• Performs and conducts P&ID walk-downs and verification of system drawings as required
• 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
• Participate in internal audits and external inspections as required
• Maintain validation documentation through the validation lifecycle

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. 

To become a validation professional, a Bachelor’s degree (usually in a laboratory science or engineering, or something similar) is the typical requirement. A lower level qualification with accompanying work experience can be a realistic alternative though especially if that role involves reading P&IDs (piping and instrumentation diagrams) such as a high purity pipe welder or pipe fitter.

If you have work experience in areas such as;

• GMP regulated manufacturing
  Or
• You are a pipefitter / plumber / pipe welder / site-foreman / instrument or boiler technicians (i.e. you can interpret technical drawings).
  Or
• You have commissioning & qualification experience in ANY INDUSTRY e.g. Oil and Gas, Food Manufacturing, Mechanical or Electrical Construction, etc.
  Or
• You work in Quality Assurance or Quality Control in the pharma industry but have to sign off on validation documents you don’t fully understand!
  Or
• You are a process / petroleum / mechanical / chemical / civil engineer or a laboratory scientist and want to move into validation.

Check out our Equipment Validation Training Course – For Starter Validation, CQV and C&Q Roles if you want to retrain for starter-level positions such as

• Validation Technician – Some pharma companies call this role:
  • Associate QA Validation Specialist
  • Equipment Validation Specialist
• CQV Engineer – Some pharma companies call this role:
  • CQV Specialist
  • C&Q Specialist

With validation roles, you could work directly for a pharmaceutical company on in-house projects or work for an engineering consultancy or engineering contractor as part of a project team on large capital projects.

Take our university accredited Pharmaceutical Validation Training Course and move into more senior-level validation CQV and C&Q roles that are more challenging and pay more. This is an intermediate to advance course where you will develop process validation protocols, plan a validation strategy and become a validation professional.

This program is university accredited by Technological University Dublin, Ireland.

The ideal skill set for someone moving into validation includes:

• Bias towards details – it is vital that validation technicians follow validation protocols precisely to ensure that the results are reliable
• Team working – will usually be working as part of a larger validation team to accomplish larger validation goals
• 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

For more information on necessary skills, check out this post where we analysed validation job adverts to discover the 8 most “in-demand” skills for validation professionals.

Check out our salary guide for Validation Technicians salary information local to you.

As with all resumes, it’s extremely important that you tailor your Validation Technician resume to reflect the language used within the job advert. Where you have relevant experience or skills, use the words and phrases that the employer has used to describe them. Do not assume that someone will read similar wording and know what you mean.

Validation Technician roles will typically be looking for the skills previously outlined:

• Attention to detail 
• Team working 
• Good communication skills 
• Mathematics 
• Computer skills 

For more help with your resume, check out these templates and this list of 30 tips to improve your resume.

For more information on currently available Validation Technician roles, head to our jobs boards and select Validation in the “Jobs by Category” menu. We currently have jobs boards for Ireland and the UK.