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…
- CQV Engineer
- C&Q Engineer
- Manager / Associate Manager – QA Validation
- QA Validation Engineer
- Quality & Validation Engineer
- Quality Assurance Engineer (Validation)
- Quality Validation Engineer
- Senior Validation Engineer
- Staff Engineer, Quality/Validation
- Validation Scientist
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 2022 salary report that engineers not fitting into its specialization groups (including validation) earned a median salary of $128,620
Pharmaceutical Validation Training Courses
The Application DEADLINE for our next Equipment Validation Training Course for starter validation, CQV and C&Q roles and Pharmaceutical Validation Training Course for more senior validation, CQV and C&Q roles is Wednesday, 4th October 2023.
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 a documented evidence trail (through rigorously checking and testing) to demonstrate 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. However final end-product testing isn’t enough.
In addition, the processes, systems, and equipment that lead to their manufacture are closely scrutinized too. Each step 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.
In addition, any changes to systems, equipment or processes within an established manufacturing system must also be validated to make they 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!)
What does a Validation Engineer Do?
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.
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 equipment 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:
– is one part of a larger validation process. Equipment validation which is more commonly referred to as equipment qualification is the regulated and documented act of proving that a mechanical, piping, software system or subsystem is installed correctly, operates as required and performs as expected under load. Qualification is normally used for:
- Ancillary systems
Qualification makes sure that a facility and the equipment in it, function as required so that it can be approved by the regulatory agencies that have jurisdiction over that facility. It makes extensive use of IQ OQ PQ or Installation Qualification, Operational Qualification, and Performance Qualification. These steps are collated in an Equipment Qualification Protocol which is a written plan that states how qualification 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 critical system 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.
Entry-level equipment qualification roles tend to focus on populating or executing a pre-written equipment qualification protocol.
As you get more experience and develop a more in-depth understanding of what you are testing, you will begin to start writing and developing these test protocols. There are a number of different job titles used for people with this role such as:
- Validation Technician – Some pharma companies call this role:
- Associate QA Validation Specialist
- Equipment Validation Specialist
- QA Validation Associate
- QA Validation Specialist
- CQV Specialist – Some pharma companies call this role:
- CQV Technician
- C&Q Specialist
- C&Q Junior Project Manager
With validation, CQV and C&Q roles, you could work directly for:
- pharmaceutical companies on in-house projects
- engineering consultancies as part of a project team on small to large capital projects
- engineering contractors as part of a project team on small to large capital projects
And with more experience:
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.
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
– 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.
– 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 GxP 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.
One of the biggest misconceptions of working in Computer System Validation is that you need to be able to code or have a software background or be able to program a PLC.
This is not the case as CSV is about managing data accuracy, reliability and integrity, not programming.
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 To Become a Validation Engineer?
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
- High emotional intelligence and great people skills – the ability to quickly build rapport with people from a wide variety of backgrounds, and to persuade, charm and cajole those people who are often outside your organisation to help with your project goals
- 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
- 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)
- Strong understanding – of pharma/biopharma manufacturing techniques and site GMPs (Good Manufacturing Practices), documentation standards and any other pharmaceutical industry regulatory requirements
- Knowledge of requirements for – design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches
For more information on this, check out this post where we analysed validation job adverts to find the 8 most “in demand” skills for validation roles.
And check out this decision-making simulation tool on “Validation Engineers | 5-Mistakes to Avoid on Your First Day“.
Validation Regulation and Guidelines
Process validation is required by the Food and Drug Administration (FDA) The FDA regulation is covered under the Process Validation: General Principles and Practices and states that process validation activities in three different stages:
- Stage 1 – process design
- Stage 2 – process qualification
- Stage 3 – continued process verification (CPV)
In addition, the FDA provide Cleaning Validation Guidelines in CFR 211.67 And an inspection reference Guide to inspections Validation of cleaning processes
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 on in house projects. These roles come with high salaries and have increased job security.
- Working for an engineering consultancy on large capital projects. These roles typical receive higher compensation.
- Working for an engineering contractor on large capital projects. These roles receive even higher compensation (typically through a higher hourly rate and a large amount of overtime available) but have limited job security.
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.
Job growth has been exceptionally strong over the last 5 years after a period of low growth following the great 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:
- Strong documentation bias
- Attention to detail
- Analytical thinking
- Enthusiasm for working in a team
- Good written communication skills
- Preference for a structured approach to working
- Computer skills
- Time management
For more help with your resume, check out these templates and this list of 30 tips to improve your resume.
How To Become A Validation Engineer?
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.
Equipment Validation Program – For Starter Validation Level Roles
Check out our Equipment Validation (IQ OQ PQ) Training Course – For Starter Validation Roles if you want to retrain for entry-level equipment validation positions such as
Validation Engineer Programs – Senior Level
Take our 30-week Pharmaceutical Validation Training Course – For Senior Validation Roles and move into positions 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).
Other Validation & Quality Roles in Pharma