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What does a validation analyst do?

Updated January 8, 2025
7 min read

Validation Analysts are responsible for the accurate review and assessments of systems and processes within an organization. For example, a model valuation analyst has the task of assessing quantitative rules and statistical models that will help banks manage credit risks and other financial risks. Their duties include evaluation of risk models, developing validation plans, conduct statistical testing, and inspecting data. They also liaise with internal stakeholders to resolve model issues, maintain findings documentation as well as prepare report for senior management.

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Validation analyst responsibilities

Here are examples of responsibilities from real validation analyst resumes:

  • Develop requirements and lead computer software FDA validation project for a diabetes management system utilize by nursing homes and physicians.
  • Involve in performing GUI, functional, integration, regression and system testing using QC.
  • Interpret, compile and review QC data adhering to strict guidelines for documentation of test procedures; reporting of scientific results.
  • Create IQ/OQ/PQ scripts for validation system.
  • Validate Glasswasher utilizing new detergent CIP 100 and CIP 200.
  • Participate in the authoring of IQ/OQ/PQ protocols for the impacted systems.
  • Apply principles of cGMP, GAMP as related to product design.
  • Analyze complete (execute) CSV protocols for adequacy and compliance.
  • Work on investigation and CAPA module and prepare final investigation summary CAPA reports.
  • Involve in development and update RTM in coordination with the project manager and CSV analyst.
  • Attend Pfizer GMP, GLP training as well as online (CBT) * validation training.
  • Perform black box testing, positive testing, negative testing, front end testing and regression testing.
  • Keep track and monitor the performance of the equipment and instruments utilize in the GMP environment laboratories.
  • Project reviews involving all phases of the SDLC to determine projects are on track and meeting expect outcome.
  • Create and monitor CAPA reports regarding compliance issues, and report to upper management on progress make to resolve open issues.

Validation analyst skills and personality traits

We calculated that 15% of Validation Analysts are proficient in QC, Regression, and SQL. They’re also known for soft skills such as Leadership skills, Interpersonal skills, and Problem-solving skills.

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

  • QC, 15%

    Reviewed approval of qualification documents for laboratory equipment's and participated in Quality Control (QC) activities.

  • Regression, 9%

    Performed Regression Testing on different modules to check compatibility and performance of application using Win Runner.

  • SQL, 9%

    Worked on Oracle database to verify the data storage process for the E Drawer System using SQL queries.

  • Validation Documentation, 8%

    Supported Quality Assurance department with client audits by providing validation documentation, clarification of testing procedures or system demonstrations as needed.

  • Corrective Action, 5%

    Documented and communicated deviations found during testing and maintained comprehensive tracking of all test deviations and associated corrective actions.

  • Validation Process, 4%

    Performed Gap analysis and developed Remediation plans for the deviations occurred during the validation processes.

Most validation analysts use their skills in "qc," "regression," and "sql" to do their jobs. You can find more detail on essential validation analyst responsibilities here:

Leadership skills. To carry out their duties, the most important skill for a validation analyst to have is leadership skills. Their role and responsibilities require that "to keep the production process running smoothly, industrial production managers must motivate and direct employees." Validation analysts often use leadership skills in their day-to-day job, as shown by this real resume: "use effective project management and leadership skills to supervise validation project teams. "

Interpersonal skills. Many validation analyst duties rely on interpersonal skills. "industrial production managers must have excellent communication skills to work well other managers and with staff," so a validation analyst will need this skill often in their role. This resume example is just one of many ways validation analyst responsibilities rely on interpersonal skills: "applied interpersonal, analytical and computer skills to troubleshoot incoming problems and disbursed cases to the appropriate information systems team members. "

Problem-solving skills. This is an important skill for validation analysts to perform their duties. For an example of how validation analyst responsibilities depend on this skill, consider that "production managers must identify and address problems that arise." This excerpt from a resume also shows how vital it is to everyday roles and responsibilities of a validation analyst: "executed oq test scripts and resolved discrepancies. ".

Most common validation analyst skills

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Compare different validation analysts

Validation analyst vs. Equipment validation engineer

In the manufacturing industry, a Senior Validation Engineer specializes in inspecting and developing tools, equipment, and procedures, ensuring they adhere to company standards. Their responsibilities typically involve understanding project requirements, performing installations and calibrations, troubleshooting problems, creating and implementing tests, and conducting extensive research and analyses. They must also maintain records of all transactions and procedures, organize and update databases, and prepare reports regularly. Moreover, as a Senior Validation Engineer, it is essential to lead and serve as a mentor to junior validation engineers, all while implementing the company's safety standards and regulations.

If we compare the average validation analyst annual salary with that of an equipment validation engineer, we find that equipment validation engineers typically earn a $5,584 higher salary than validation analysts make annually.While the two careers have a salary gap, they share some of the same responsibilities. Employees in both validation analyst and equipment validation engineer positions are skilled in test scripts, fda, and iq/oq/pq.

These skill sets are where the common ground ends though. The responsibilities of a validation analyst are more likely to require skills like "qc," "regression," "sql," and "validation documentation." On the other hand, a job as an equipment validation engineer requires skills like "equipment validation," "sops," "provides technical support," and "quality system." As you can see, what employees do in each career varies considerably.

On average, equipment validation engineers reach lower levels of education than validation analysts. Equipment validation engineers are 9.8% less likely to earn a Master's Degree and 1.0% less likely to graduate with a Doctoral Degree.

Validation analyst vs. Senior validation engineer

The pioneering person to manage, inspect, calibrate, test, and modify an operating system is referred to as a System Validation Engineer. Such a person does ensure all systems are running smoothly.

A career as a senior validation engineer brings a higher average salary when compared to the average annual salary of a validation analyst. In fact, senior validation engineers salary is $21,662 higher than the salary of validation analysts per year.Only some things about these jobs are the same. Take their skills, for example. Validation analysts and senior validation engineers both require similar skills like "qc," "regression," and "corrective action" to carry out their responsibilities.

While some skills are similar in these professions, other skills aren't so similar. For example, resumes show us that validation analyst responsibilities requires skills like "sql," "validation documentation," "validation process," and "traceability matrix." But a senior validation engineer might use other skills in their typical duties, such as, "project management," "process validation," "process equipment," and "iso."

Senior validation engineers earn a higher average salary than validation analysts. But senior validation engineers earn the highest pay in the pharmaceutical industry, with an average salary of $99,979. Additionally, validation analysts earn the highest salaries in the finance with average pay of $88,478 annually.senior validation engineers earn lower levels of education than validation analysts in general. They're 5.1% less likely to graduate with a Master's Degree and 1.0% more likely to earn a Doctoral Degree.

Validation analyst vs. System validation engineer

Analysts are employees or individual contributors with a vast experience in a particular field that help the organization address challenges. They help the organization improve processes, policies, and other operations protocol by studying the current processes in place and determining the effectiveness of those processes. They also research industry trends and data to make sound inferences and recommendations on what the company should do to improve their numbers. Analysts recommend business solutions and often help the organization roll out these solutions. They ensure that the proposed action plans are effective and produce the desired results.

An average system validation engineer eans a higher salary compared to the average salary of validation analysts. The difference in salaries amounts to system validation engineers earning a $7,696 higher average salary than validation analysts.By looking over several validation analysts and system validation engineers resumes, we found that both roles require similar skills in their day-to-day duties, such as "regression," "sql," and "fda." 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 analyst resumes include skills like "qc," "validation documentation," "corrective action," and "validation process," whereas a system validation engineer is more likely to list skills in "python," "c #," "architecture," and "debug. "

System validation engineers earn the best pay in the technology industry, where they command an average salary of $94,689. Validation analysts earn the highest pay from the finance industry, with an average salary of $88,478.When it comes to education, system validation engineers tend to earn similar degree levels compared to validation analysts. In fact, they're 0.5% less likely to earn a Master's Degree, and 0.8% less likely to graduate with a Doctoral Degree.

Validation analyst vs. Analyst

Analysts average a lower salary than the annual salary of validation analysts. The difference is about $11,619 per year.While their salaries may vary, validation analysts and analysts both use similar skills to perform their duties. Resumes from both professions include skills like "test scripts," "test cases," and "qa. "

Even though a few skill sets overlap between validation analysts and analysts, there are some differences that are important to note. For one, a validation analyst might have more use for skills like "qc," "regression," "sql," and "validation documentation." Meanwhile, some responsibilities of analysts require skills like "customer service," "troubleshoot," "data analysis," and "management system. "

Analysts enjoy the best pay in the technology industry, with an average salary of $79,330. For comparison, validation analysts earn the highest salary in the finance industry.analysts reach lower levels of education compared to validation analysts, in general. The difference is that they're 10.1% more likely to earn a Master's Degree, and 0.3% more likely to graduate with a Doctoral Degree.

Types of validation analyst

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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