What is a Validation Engineer? What do they do?

They also plan, implement and monitor the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.

• 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

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 2023 salary report that engineers not fitting into its specialization groups (including validation) earned a mean or average salary of $118,620

The application deadline for our next Equipment Validation Training Course for starter validation, CQV and C&Q roles, as well as our Pharmaceutical Validation Training Course for more senior validation, CQV and C&Q roles is Wednesday 7th August

Let’s take a closer look at the details of validation and the role of a validation engineer.

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:

1. Maintains compliance at all stages
2. Leads to a consistent and reproducible result

There are many other definitions of validation but the essence of all these definitions is “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 is not enough.

The processes, systems, and equipment used in manufacturing are also closely scrutinized. 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 to manufacture and distribution.

Furthermore, any changes to systems, equipment, or processes within an established manufacturing system must also be validated to ensure 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!)

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 a particular validation role. 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 support for regulatory audits, submissions and other auditor requests
• Write and populate validation protocols such as equipment validation protocols process validation protocols,  cleaning validation protocols, etc,
• Develop and run test protocols
• Ensure projects are managed in compliance with regulatory requirements such as health & safety, cGMP, construction, and environmental standards
• Develop and write commissioning, qualification and validation documents following established standards and templates.
• Perform 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 abnormal testing results and address issues identified by other staff members
• Ensure accurate records of all validation activities
• Supervise junior staff or management of a team of validation professionals

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.

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.

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:

Equipment validation, also referred to as equipment qualification, is one part of a larger validation process. It involves 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:

• Equipment
• Ancillary systems
• Instruments
• Utilities (Purified Water, Steam, Air, etc)

Qualification makes sure that a facility and its equipment function as required so that it can be approved by the regulatory agencies. It uses  IQ OQ and 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, written for each critical system, outlines the steps and measurements required, the proof needed, the expected outcomes, and actions to take if actual outcomes deviate.

Entry-Level Roles and Progression

Entry-level equipment qualification roles focus on populating or executing a pre-written equipment qualification protocol. With more experience and a deeper understanding of the testing, individuals begin to write and develop these test protocols.

Job Titles for Equipment Qualification Roles

• 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

Career Paths

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

With more experience, roles can progress to:

• CQV Engineer

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.

Typical Background

Paths to a role in equipment validation include:

• Experience as a plumber/pipefitter/pipe welder (e.g., high purity pipe fitter and orbital welder), site foreman, or instrument/boiler technician (i.e., interpreting technical drawings, especially P&IDs and pipe skids).
• GMP manufacturing experience or a recognized GMP certificate or qualification.
• Commissioning & qualification experience in industries like oil and gas, food manufacturing, or mechanical construction.
• Experience in quality assurance or quality control in the pharma/Medtech industry.
• Education or experience as a chemical, process, petroleum, project, or mechanical engineer, or as 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. It is generally considered an advanced role requiring thorough process knowledge and experience. Process validation engineers typically work in engineering design, tech transfer, and upstream and downstream manufacturing.

Typical background

Most practitioners have a background in lab/science, chemistry, or chemical/process engineering, or have learned experientially through extensive work experience.

Design and develop cleaning procedures for new products and manufacturing equipment. Professionals in this field also investigate and conduct troubleshooting/root cause analysis of cleaning-related incidents and deviations involving non-validated or underdeveloped cleaning procedures.

Typical Background

This is a highly specialized role requiring in-depth knowledge of chemical cleaning processes. Most practitioners have a background in lab science, chemistry, or chemical/process engineering, though some gain expertise through extensive work experience or on-the-job training.

CSV 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. This process ensures the system is 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 focuses on managing data accuracy, reliability, and integrity, not programming.

Typical background

Despite being a specialized role, there are many paths to working in computer system validation, including:

• 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

The ideal skill set for someone moving into validation includes:

• Strong documentation skills – Managing and documenting the entire validation process. The documentation must comply with both internal SOPs and external regulations.
• Attention to detail – Paying close attention to every test result and measurement, and noticing when something isn’t right.
• Analytical thinking – Identifying issues, suggesting potential causes, and proposing fixes.
• Teamwork – Validation of equipment systems is a team activity requiring good verbal and listening skills to share information among team members.
• High emotional intelligence and people skills – Building rapport with people from diverse backgrounds, and persuading and motivating those outside your organization to help achieve project goals.
• Good written communication skills – Report and protocol writing is an essential part of the job.
• Structured approach to working – Your work will impact others in the validation team, requiring document sharing and signing with multiple team members.
• Time management – Following a testing timeline.
• Initiative – Thinking on your feet and coming up with new and inventive ways to challenge processes and fix problems.
• Problem-solving skills – Using risk management tools such as Fault Tree Analysis (FTA), Cause and Effect Diagram, Failure Mode and Effects Analysis (FMEA), Preliminary Hazard Analysis (PHA), Hazard Operability Analysis (HAZOP), Event Tree Analysis (ETA), and Hazard Analysis and Critical Control Points (HACCP).
• Strong understanding of pharma/biopharma manufacturing – Knowledge of GMPs (Good Manufacturing Practices), documentation standards, and other pharmaceutical industry regulatory requirements.
• Knowledge of design, installation, commissioning, qualification, and validation – Using risk-based approaches for pharmaceutical equipment, systems, and utilities.

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“.

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. 

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 typically 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 2023 salary report that engineers not fitting into its specialization groups (including validation) earned a mean or average salary of $118,620.

Job growth has been exceptionally strong over the last 5 years after a period of low growth following the Great Recession.

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
• Mathematics
• Computer skills
• Time management
• Initiative

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

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 or Master’s degree in a lab/science field (such as biochemistry, microbiology, or laboratory science) or an engineering field (such as mechanical, petroleum, process, structural, chemical, mining, or electrical engineering) is typically required. However, 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.

Check out our 15-week 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 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 Junior Engineer
  • C&Q Specialist
  • C&Q Junior Project Manager

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 advanced 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 at NFQ Level 7 by Technological University Dublin, Ireland. 

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.

Validation

• CQV Engineer
• Validation Technician
• CSV Engineer

Quality

• Quality Engineer
• Documentation Specialist
• Quality Assurance Specialist
• Quality Control Analyst