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What does a Validation Specialist do?

Learn all about Validation Specialist duties, skills and much more. Get expert advice on how to become a Validation Specialist.

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Brenna Goyette
Certified Professional Resume Writer, Career Expert

Published 3 min read

A Validation Specialist is responsible for ensuring that products or processes meet all relevant regulatory requirements. They may develop and implement validation plans, test methods, and quality standards. Additionally, they may train other staff on validation procedures and oversee the execution of validation projects.

Validation Specialist job duties include:

  • Develop and execute validation plans for new and existing products, processes, and systems
  • Write validation protocols and reports
  • Perform data analysis to support validation activities
  • Identify process improvements to reduce validation effort and improve product quality
  • Train employees on proper validation procedures
  • Maintain current knowledge of regulatory requirements for validation
  • Interface with regulatory agencies during audits and inspections
  • Manage change control procedures for validated products, processes, and systems
  • Investigate process deviations and implement corrective actions

Validation Specialist Job Requirements

A Validation Specialist typically requires a Bachelor's degree in a scientific discipline, as well as experience working in a regulated environment. Certification as a Quality Engineer or Auditor is also preferred. The Validation Specialist will be responsible for developing and executing validation protocols and reports for new and existing products, processes, and systems. They will also be responsible for ensuring compliance with regulatory requirements.

Validation Specialist Skills

  • FDA regulations
  • GMP
  • SOP
  • Computer System Validation
  • Equipment validation
  • Process validation
  • Cleaning validation
  • Packaging validation
  • Labeling validation
  • Storage validation
  • Transportation validation

Related: Top Validation Specialist Skills: Definition and Examples

How to become a Validation Specialist

A validation specialist is a professional who ensures that products, processes, and systems meet the requirements of the customers or regulatory agencies. There are many ways to become a validation specialist. One way is to have a degree in engineering, science, or another technical field. Another way is to have experience working in quality assurance or another relevant field.

The most important thing for a validation specialist is to have strong analytical and problem-solving skills. They must be able to understand complex systems and identify potential problems. They must also be able to develop and implement solutions to these problems.

If you are interested in becoming a validation specialist, there are many resources available to help you get started. There are online courses, books, and articles that can provide you with the knowledge you need. You can also find mentors or other professionals who can help guide you through the process.

Becoming a validation specialist can be a rewarding career choice. It allows you to use your skills to improve products and processes and make a difference in the lives of others.

Related: Validation Specialist Resume Example

Related: Validation Specialist Interview Questions (With Example Answers)