Validation Engineer  What They Do

Just the Facts

Designs or plans protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.

This career is part of the Science, Technology, Engineering and Mathematics cluster Engineering and Technology pathway.

A person in this career:

  • Analyzes validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
  • Prepares validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
  • Coordinates the implementation or scheduling of validation testing with affected departments and personnel.
  • Studies product characteristics or customer requirements and confers with management to determine validation objectives and standards.
  • Creates, populates, or maintains databases for tracking validation activities, test results, or validated systems.
  • Prepares, maintains, or reviews validation and compliance documentation, such as engineering change notices, schematics, or protocols.
  • Resolves testing problems by modifying testing methods or revising test objectives and standards.
  • Prepares detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
  • Identifies deviations from established product or process standards and provides recommendations for resolving deviations.
  • Directs validation activities, such as protocol creation or testing.

Working Conditions and Physical Demands

People who do this job report that:

  • You would sit most of the time. There's some walking and standing. You may have to lift and carry things like books, papers or tools weighing 10 lbs. or less.
  • Work in this occupation involves use of protective items such as safety shoes, glasses, gloves, hearing protection, a hard hat, or personal flotation devices
  • Work in this occupation requires being inside most of the time
  • Sound and noise levels are loud and distracting
  • Work in this occupation involves sitting more than one-third of the time
  • Work in this occupation involves standing more than one-third of the time

Working in this career involves (physical activities):

  • Seeing clearly up close
  • Speaking clearly enough to be able to be understood by others
  • Identifying and understanding the speech of another person

Work Hours and Travel

  • Regular working hours and limited travel

Specialty and Similar Careers

Careers that are more detailed or close to this career:

  • Corporate Quality Engineer --
  • Corporate Quality Manager --
  • Quality and Reliability Engineer --
  • Quality Assurance Engineer --
  • Quality Coordinator --
  • Quality Director --
  • Quality Engineer --
  • Quality Specialist --
  • Supplier Quality Engineer --
  • Validation Specialist --