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 2020 salary report that engineers not fitting into its specialization groups (including validation) earned a median salary of $119,670.
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. Each of these roles focuses on a different part of the manufacturing pathway and can serve as a validation speciality. Examples include:
– creating an evidence trail to show that an action, process, or system leads to a consistent and reproducible result. This area contains Prospective Validation, Concurrent Validation, Retrospective Validation, and Revalidation. This is generally considered an advanced role and requires thorough process knowledge and experience with process validation engineers working in engineering design, tech-transfer, upstream and downstream manufacturing.
Most practitioners tend to have a lab/science, chemistry or chemical/process engineering background although or have learnt experientially on the job through extensive work experience.
– is one part of a larger validation process for making sure that a facility and the equipment in it – will function as required and be approved by the regulatory agencies that have jurisdiction over that facility. Equipment validation makes extensive use of IQ, OQ, and PQ or Installation Qualification, Operational Qualification, and Performance Qualification and IQ OQ PQ Equipment Validation Protocols, and testing and verification which focuses on whether systems and processes are meeting predefined specifications.
The paths to a role working as in equipment validation are many and include:
You are a plumber/pipefitter/pipe welder (e.g. high purity pipe fitter and orbital welder) / site-foreman / instrument or boiler technicians (i.e. you can interpret technical drawings, especially P&IDs and pipe skids).
You have GMP manufacturing experience or have a recognized GMP certificate or qualification.
You have commissioning & qualification experience in oil and gas, food manufacturing, mechanical construction, etc.
You work in quality assurance or quality control in the pharma/Medtech industry.
You are a chemical / process / petroleum / project / mechanical engineer or a lab/scientist
People often progress onto senior validation roles which include the responsibility for developing the master validation plan and planning and overseeing all validation activities such as process validation, computer system validation and cleaning validation.
– design and develop cleaning procedures for new products and manufacturing equipment. Those who work in cleaning validation also investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations for non validated or underdeveloped cleaning procedures.
This is a highly specialised role requiring in-depth knowledge of chemical cleaning processes so most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience or on-the-job training.
–is a process used to prove (and document) that a computer-based system will produce information or data the way it is designed to and not perform in ways that weren’t intended. The CSV process is necessary when replacing paper records with electronic systems within highly regulated environments that directly impact public health and safety, such as pharmaceutical and medical device manufacturing. Its use makes sure that the system is completely accurate, transparent, reliable, robust, and tamper-proof.
Although this is a highly specialised role, the paths to working in computer system validation are many and include:
Senior validation, process validation, equipment validation, CQV validation engineers
Laboratory science/chemistry background.
Automation, instrumentation or calibration engineers
Computer science, computer engineering, computer information systems background
Quality assurance or quality control specialists
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
In Europe, Annex 15: Qualification and Validation provide guidance on qualification, DQ, IQ, OQ PQ qualification, process validation including concurrent validation, continuous process verification and cleaning validation.
The ISPE Baseline® Guide: Commissioning and Qualification provides guidance on the implementation on a risk-based approach for the commissioning and qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are fit for intended use.
Salaries and Job Growth
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.
(Note that actual job titles will 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).