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.
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.
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
Becoming a Validation Technician
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.
Retrain to Become a Validation Technician
If you have work experience in areas such as;
GMP regulated manufacturing
You are a pipefitter / plumber / pipe welder / site-foreman / instrument or boiler technicians (i.e. you can interpret technical drawings).
You have commissioning & qualification experience in ANY INDUSTRY e.g. Oil and Gas, Food Manufacturing, Mechanical or Electrical Construction, etc.
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!
You are a process / petroleum / mechanical / chemical / civil engineer or a laboratory scientist and want to move into validation.
(Note that actual job titles may vary – the distinction is more between who’d employ you and what type of projects you’d work on).
Validation Engineer Programs – Senior Level
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.
What Skills Do I Need?
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
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:
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.