Validation Engineer Job Description

Validation engineers plan, create, and execute tests that check if a company’s manufacturing equipment produces products that meet performance, quality, and industry-specific safety standards. Their understanding of manufacturing processes and data analysis helps them prevent and fix issues, working with management to improve the company’s manufacturing processes. This role is suitable for bachelor’s degree holders with very strong communication and problem-solving skills. Most validation engineers work full-time in a plant environment for firms that often produce medical or technological products.


Validation Engineer Duties and Responsibilities

While a validation engineer’s day-to-day duties and responsibilities are determined by where they work, there are many core tasks associated with the role. Based on our analysis of job listings, these include:

Calibrate Manufacturing Equipment

To prevent issues with quality and performance during production, validation engineers look at parameters, such as accuracy and tolerance, and compare the company’s products against these measurements and industry standards. They then calibrate manufacturing equipment that does not meet or exceed the accepted levels.

Design and Perform Validation Tests

Validation engineers work with management and others in production to create tests that measure the performance and quality of items the company’s equipment produces. This includes designing a list of standards and metrics and choosing the software, tools, and format for such tests. They then carry out these tests to produce data to analyze.

Analyze Equipment Test Results

Using data analysis techniques and software, validation engineers look at validation test results to determine the main cause of defects, safety risks, and performance problems. They also use the data to provide a risk assessment and check for adherence to government standards, such as the Food and Drug Administration (FDA) for medical equipment production.

Correct Quality Issues

Correcting the issues found in the tests can include recalibrating equipment, repairing machinery, or changing the company’s processes or products to meet standards and reduce risks. Validation engineers may also meet with management to develop quality or process improvement plans for the long term.

Create Reports and Documentation

While developing, running, and analyzing tests or making changes, validation engineers create documentation that records all steps taken and all measurements considered for future reference. This documentation helps them later run audits, troubleshoot, and provide these materials to prove compliance when necessary.


Validation Engineer Skills and Qualifications

Successful validation engineers are skilled analysts who can develop ways to generate and inspect complex data to solve problems. In addition to a bachelor’s degree and work experience as a quality tester and validator, employers look for validation engineers who possess the following:

  • Understanding of manufacturing processes – validation engineers understand how machinery works to produce goods such as medical equipment, vehicles, and computer hardware, understanding the steps for manufacturing these items and the industry standards they must adhere to
  • Quality testing – whether designing or carrying out tests, validation engineers know what factors to observe and how to structure tests for accurate and useful results
  • Data analysis – validation engineers take complex data gathered from tests and use computer software to analyze the data for trends that show quality and performance issues that need further attention
  • Troubleshooting – fixing errors observed in test results requires validation engineers to look at possible causes for problems with the manufacturing equipment and determine the best solution to prevent defective goods
  • Communication skills -a validation engineer’s work requires strong writing skills to write test plans, record results, and create documentation; interacting with management and production workers necessitates clear and effective communication


Tools of the Trade

Validation engineers often use these tools and applications at work:

  • Statistical analysis software (MATLAB, Minitab, QXDM Pro)
  • Database management systems (MongoDB, Microsoft Access, MySQL)


Validation Engineer Education and Training

Most employers require validation engineers to hold a bachelor’s degree in quality management, statistics, manufacturing, engineering, or a related field. Areas of study can include data analysis, statistics, quality assurance management, regulatory compliance, computer programming, technical writing, and fundamentals of manufacturing equipment. Those interested in promotion to a lead validation engineer or manager role may earn a master’s degree in engineering or quality management. While many employers do not require certification, the American Society for Quality (ASQ) offers numerous quality engineering certification options.


Validation Engineer Salary and Outlook

The Bureau of Labor Statistics (BLS) places validation engineers in a broad category of engineers, listing a median annual wage of $97,250 for this category. Validation engineers in the 10th percentile make around $50,600, and those with the top pay earn over $154,700 annually. Large companies employing validation engineers often provide insurance benefits packages and paid time off for vacations, illnesses, and holidays.

Employment of validation engineers is expected to grow 6 percent through 2026. This is an average rate of growth, but it is slightly slower than the 8 percent growth expected for engineers in general. Having around five years of validation work experience and experience with industry tools and applications can improve prospects.


Helpful Resources

We’ve collected some resources that can put you on the way to becoming a validation engineer:

Society of Quality Assurance – This organization offers students and quality assurance professionals membership opportunities with access to mentorship, webinars, training programs, and exclusive content and whitepapers.

Building Quality Management Systems: Selecting the Right Methods and Tools – New validation engineers can use this manual to learn to select appropriate testing methods and tools based on testing needs. It also helps them overcome challenges with test implementation.

American Society for Quality – Connecting quality management professionals around the world, this organization provides guidance on quality standards. It offers 18 quality certifications, provides networking opportunities, and has a comprehensive database with resources for measuring and improving quality.

The Handbook for Quality Management: A Complete Guide to Operational Excellence – Using recent standards from the American Society of Quality Management, this in-depth handbook guides quality management professionals through planning quality assessments, setting benchmarks, controlling processes, conducting audits, and analyzing results.


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