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What does a validation engineer do?

Updated January 8, 2025
7 min read
Quoted expert
Edoardo Sarda Ph.D.

A validation engineer is an individual responsible for managing, inspecting, testing, and modifying the instrumentation, equipment, mechanics, and procedures for the production of high-quality products. The professional's tasks include analyzing test results, preparing compliance reports, and keeping updated with industry standards and regulations. Validation engineers should possess core skills such as strong mathematical and information technology skills and the ability to resolve complex engineering problems. Possessing a bachelor's or master's degree in a relevant engineering discipline is an advantage to qualify for the position.

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Validation engineer responsibilities

Here are examples of responsibilities from real validation engineer resumes:

  • Manage the DFMEA and risk assessment/mitigation as development are on-going.
  • Manage a team of 15 technicians testing Intel's wireless products across all Microsoft's OS offerigns.
  • Coordinate a division of labor and manage next steps to validate SVM on Broadwell (BDW) client CPU.
  • Manage CSV quality compliance by meeting factory, corporate, federal and foreign inspections demonstrating regulatory control with no major findings.
  • Work with end users from different departments, possess strong analytical and risk assessment skills and managing multiple GLP system projects.
  • Coordinate and manage daily CIP validation testing activities.
  • Flash EMMC with current firmware & OS.
  • Work with design architecture teams for low level debug of vary IP groups with in the CPU core.
  • Set up, re/configure and maintain platform health per new firmware releases and BIOS updates (ECO).
  • Perform validation testing of prototype and line switches, assembling test data for use by in-house and customer engineering staffs.
  • Experience with the following interfaces PCI, PCIe, FSB, and some USB.
  • Develop and test algorithms using python script to meet system objectives.
  • Apply principles of cGMP, GAMP as related to process design.
  • Provide SME services for the installation of a new passivation line.
  • Install all Microsoft OS and Linux on prototypes throughout the development cycle to ensure compatibility.

Validation engineer skills and personality traits

We calculated that 7% of Validation Engineers are proficient in Python, FDA, and GMP. They’re also known for soft skills such as Leadership skills, Time-management skills, and Problem-solving skills.

We break down the percentage of Validation Engineers that have these skills listed on their resume here:

  • Python, 7%

    Developed and modified test Script & modular test suites using Python for various Mobile applications - targeting Sanity & Stability testing.

  • FDA, 6%

    Initiated, controlled and executed validation processes and procedures for engineering as required by the FDA and other medical device regulatory systems

  • GMP, 6%

    Prepared and reviewed installation qualification protocols for utilities; process and process support equipment for a GMP facility.

  • Medical Devices, 5%

    Develop and write validation Installation/Operation Qualifications (IQ/OQ) for equipment used in manufacturing of medical devices.

  • Test Results, 4%

    Improved accuracy/integrity of scientific calculations used in final test results by incorporating in-house formulas previously calculated in Excel.

  • Data Analysis, 4%

    Supported product development in development of design verification testing methods, sample size selection, and data analysis.

"python," "fda," and "gmp" are among the most common skills that validation engineers use at work. You can find even more validation engineer responsibilities below, including:

Leadership skills. One of the key soft skills for a validation engineer to have is leadership skills. You can see how this relates to what validation engineers do because "to keep the production process running smoothly, industrial production managers must motivate and direct employees." Additionally, a validation engineer resume shows how validation engineers use leadership skills: "executed protocols and wrote final reports documenting results for leadership and fda audits. "

Problem-solving skills. validation engineers are also known for problem-solving skills, which are critical to their duties. You can see how this skill relates to validation engineer responsibilities, because "production managers must identify and address problems that arise." A validation engineer resume example shows how problem-solving skills is used in the workplace: "managed and designed retest plans and coordinated post deviation resolution activities to ensure compliance with established client and fda regulations. "

See the full list of validation engineer skills

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Compare different validation engineers

Validation engineer vs. Equipment validation specialist

A Project Engineer develops the plan that the entire team or company will undertake. The project engineer develops the plans, strategies, and goals of a project and then gives it to the management for approval and allocation. The Project Engineer will also recommend material, equipment, and the type of personnel needed. This position is integral in the smooth flow of any project, so hiring someone to hold this position will decide the success of a project.

We looked at the average validation engineer salary and compared it with the wages of an equipment validation specialist. Generally speaking, equipment validation specialists are paid $7,889 lower than validation engineers per year.While their salaries may differ, the common ground between validation engineers and equipment validation specialists are a few of the skills required in each roleacirc;euro;trade;s responsibilities. In both careers, employee duties involve skills like gmp, qa, and r.

While similarities exist, there are also some differences between validation engineers and equipment validation specialist. For instance, validation engineer responsibilities require skills such as "python," "fda," "medical devices," and "test results." Whereas a equipment validation specialist is skilled in "oq," "maximo," "equipment repair," and "osha." This is part of what separates the two careers.

Equipment validation specialists tend to reach similar levels of education than validation engineers. In fact, equipment validation specialists are 2.5% less likely to graduate with a Master's Degree and 0.9% less likely to have a Doctoral Degree.

Validation engineer vs. Senior validation specialist

Engineers are highly trained professionals who determine the feasibility of various projects, usually related to the construction industry. They are considered experts in mathematics and science, two disciplines that they need to use in designing and coming up with plans for projects. They should also be well-versed in different construction or industrial materials, and they ensure that appropriate materials are used for the project. They also ensure that the projects meet the requirements of the groups that hired them. They create spaces that would both address the needs of the end-users and the industry standards. They also ensure that the projects they make would stand the test of time.

Senior validation specialist positions earn higher pay than validation engineer roles. They earn a $12,910 higher salary than validation engineers per year.While the salary may differ for these jobs, they share a few skills needed to perform their duties. Based on resume data, both validation engineers and senior validation specialists have skills such as "fda," "gmp," and "process validation. "

Each career also uses different skills, according to real validation engineer resumes. While validation engineer responsibilities can utilize skills like "python," "medical devices," "test results," and "data analysis," senior validation specialists use skills like "regulatory compliance," "delta," "microbiology," and "validation projects."

Senior validation specialists earn a higher average salary than validation engineers. But senior validation specialists earn the highest pay in the pharmaceutical industry, with an average salary of $94,923. Additionally, validation engineers earn the highest salaries in the technology with average pay of $91,160 annually.In general, senior validation specialists achieve lower levels of education than validation engineers. They're 7.4% less likely to obtain a Master's Degree while being 0.9% less likely to earn a Doctoral Degree.

What technology do you think will become more important and prevalent for validation engineers in the next 3-5 years?

Edoardo Sarda Ph.D.Edoardo Sarda Ph.D. LinkedIn profile

Assistant Professor, Robotics Engineering, Lake Superior State University

It's evident that social distancing regulations have already affected our way of life, including our work routine, and will continue to do so for the near future. This is only going to accelerate the growth of robotics and automation that we had already been experiencing in recent years. A human working closely with a robot is still tolerated, while multiple humans being close to each other is becoming less acceptable. Besides, robots are not affected by any sort of virus, including COVID19 (the exception being computer viruses, of course). This tells me that the trend towards human-robot collaboration will become more dominant as the regulations for social distancing become stricter in the industry. Mobile robots represent another technology that may gain popularity, due to the pandemic. Applications that require non-stationary, autonomous systems, such as disinfecting facilities, greeting people, serving customers, and others, will benefit from using mobile robots.

Validation engineer vs. Project engineer

An average project engineer eans a lower salary compared to the average salary of validation engineers. The difference in salaries amounts to project engineers earning a $6,954 lower average salary than validation engineers.By looking over several validation engineers and project engineers resumes, we found that both roles require similar skills in their day-to-day duties, such as "fda," "iq oq pq," and "iso." But beyond that, the careers look very different.

Some important key differences between the two careers include a few of the skills necessary to fulfill the responsibilities of each. Some examples from validation engineer resumes include skills like "python," "gmp," "medical devices," and "test results," whereas a project engineer is more likely to list skills in "project management," "autocad," "construction management," and "cad. "

Project engineers make a very good living in the energy industry with an average annual salary of $85,761. On the other hand, validation engineers are paid the highest salary in the technology industry, with average annual pay of $91,160.Most project engineers achieve a lower degree level compared to validation engineers. For example, they're 5.5% less likely to graduate with a Master's Degree, and 0.3% less likely to earn a Doctoral Degree.

Validation engineer vs. Engineer

Engineers average a higher salary than the annual salary of validation engineers. The difference is about $10,073 per year.According to resumes from validation engineers and engineers, some of the skills necessary to complete the responsibilities of each role are similar. These skills include "python," "data analysis," and "iq oq pq. "Each job also requires different skills to carry out their responsibilities. A validation engineer uses "fda," "gmp," "medical devices," and "test results." Engineers are more likely to have duties that require skills in "cloud," "c++," "c #," and "aws. "The automotive industry tends to pay the highest salaries for engineers, with average annual pay of $97,672. Comparatively, the highest validation engineer annual salary comes from the technology industry.In general, engineers hold lower degree levels compared to validation engineers. Engineers are 5.2% less likely to earn their Master's Degree and 0.4% more likely to graduate with a Doctoral Degree.

Types of validation engineer

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

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