5.03 What Is a Validation Engineer and what do they do? UPDATE MONTHLYGerard Creaner
What is a Validation Engineer and what do they do?
What is a Validation Engineer?
Validation Engineers rigorously test and pre-test the systems used to manufacture products. They inspect, measure, analyze, audit, calibrate and test the instrumentation, equipment, machines and procedures. While doing this, they create and document an evidence trail to show that the systems and equipment used, produce a defect-free consistent result. This ensures that the product is consistently of the highest quality.
They also plan, implement and monitor the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.
Some Companies Might Call This Role…
How Much do Validation Engineers Make?
There is currently a high demand for trained validation engineers. As a result, salaries are highly competitive. The United States Bureau of Labor Statistics (BLS) has indicated in its May 2018 salary report that engineers not fitting into its specialization groups (including validation) earned a median salary of $96,980.
Let’s take a closer look at the details of validation and the role of a validation engineer.
What Is Validation?
Validation is 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.
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.
Validation is not only important in the establishment of manufacturing protocols but it 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.
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.
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:
Lead validation projects and complete all associated project documentation in line with regulatory expectations
Manage, coordinate and guide the execution of the site validation master plan
Provide the relevant support for regulatory audits, submissions and other auditor requests
Populate 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)
Develop and run test protocols
Ensure projects are managed in conjunction with all regulatory requirements such as health & safety, cGMP, construction, environmental, etc
Develop and write commissioning, qualification and validation documents following established standards and templates.
Perform and conduct P&ID walk-downs and verification of system drawings
Ensure the validation status of equipment and systems are in compliance with cGMPs at all times.
Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments
Review design deliverables from engineering including drawings, datasheets, specifications and engineering lists
Maintain validation documentation through the validation lifecycle
Provide evidence of both internal and external regulatory compliance
Troubleshoot in the event of abnormal testing results
Troubleshoot issues identified by other staff members
Ensure accurate records of all validation activities
Supervise 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.
Watch this Video on a Validation Engineer’s Role!
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.
Types of Validation and Related Roles
Even within pharmaceutical and medical device manufacturing, there are several types of validation roles. Examples include:
Process Validation (itself containing Prospective Validation, Concurrent Validation, Retrospective Validation and Revalidation)
Each of these roles focuses on a different part of the manufacturing pathway and can serve as a validation speciality.
Other roles such as Qualification and Verification positions are closely related to Validation…
Qualification further divides into IQ, OQ, and PQ or Installation Qualification, Operational Qualification and Performance Qualification.
Verification focuses on whether systems and processes are meeting predefined specifications (where validation is concerned with whether the output of that system or process is consistent and reliably meeting the needs of the user).
What Skills Do I Need?
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
Very strong problem-solving skills – using risk management tools such as – Fault Tree Analysis (FTA), Cause and Effect Diagram, Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC), Preliminary Hazard Analysis (PHA), Hazard Operability Analysis (HAZOP) –TC, Event Tree Analysis (ETA). Hazard Analysis and Critical Control Points (HACCP)
Good technical knowledge – of pharma/biopharma manufacturing techniques and procedures
Knowledge of requirements for – design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches
Strong understanding – of pharmaceutical industry regulatory requirements
Knowledge of the plant equipment – including API vessels, reactors, pumps, heat exchangers, piping, flow transmitters, temperature transmitters, etc
Good understanding of how typical equipment/piping systems work
Validation Engineers are well-paid. Salaries can vary considerably depending on whether you are:
Working directly for a pharmaceutical or medical device company. These roles come with high salaries and have increased job security.
Working for engineering consultancy as a contractor. These roles receive even higher compensation (typically through a higher hourly rate and a large amount of overtime available) but have less job security.
The United States Bureau of Labor Statistics (BLS) lists the median salary at US$90,010 per year. Top reported salaries are well in excess of US$100,000.
Job growth has been exceptionally strong over the last 5 years after a period of low growth following the last recession.
Validation Engineer Resume Tips
As with all resumes, it’s extremely important that you tailor your Validation Engineer 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 roles will typically be looking for experience or a thorough understanding of validation processes, regulations, and documentation as well as the skills previously outlined:
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 lab/science (biochemistry, microbiology, laboratory science) or engineering (mechanical, petroleum, process, structural, chemical, mining, electrical or something similar) is the typical requirement but this is not always the case.
A lower-level qualification with accompanying relevant work experience especially if it involves interpreting technical drawings can be absolutely realistic alternative.
Validation Engineer Programs – Starter Level
You have GMP manufacturing experience Or
You are a pipefitters / plumbers / pipe welders / 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 but have to sign off on validation documents you don’t fully understand! Or
You are a graduate engineer / chemical engineer / lab/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 30-week Pharmaceutical Validation Training Course – For Senior Roles and move into senior-level validation 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 delivered online and is university accredited by Technological University Dublin, Ireland.
Validation Engineering Job Vacancies
Check out our jobs boards for Ireland, the UK for an idea of the number of positions currently available in your area and their salaries (select Validation from the “Jobs by Category” menu).