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Career Description

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

What Job Titles Validation Engineers Might Have

• Quality Director
• Quality Engineer
• Supplier Quality Engineer
• Validation Specialist

What Validation Engineers Do

• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
• Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
• Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
• Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
• Resolve testing problems by modifying testing methods or revising test objectives and standards.
• Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
• Identify deviations from established product or process standards and provide recommendations for resolving deviations.
• Direct validation activities, such as protocol creation or testing.
• Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
• Communicate with regulatory agencies regarding compliance documentation or validation results.
• Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
• Design validation study features, such as sampling, testing, or analytical methodologies.
• Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
• Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
• Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
• Draw samples of raw materials, or intermediate and finished products for validation testing.
• Procure or devise automated lab validation test stations or other test fixtures and equipment.
• Maintain validation test equipment.

What Validation Engineers Should Be Good At

• Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Written Comprehension - The ability to read and understand information and ideas presented in writing.
• Oral Expression - The ability to communicate information and ideas in speaking so others will understand.
• Written Expression - The ability to communicate information and ideas in writing so others will understand.
• Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.
• Problem Sensitivity - The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
• Inductive Reasoning - The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
• Category Flexibility - The ability to generate or use different sets of rules for combining or grouping things in different ways.
• Near Vision - The ability to see details at close range (within a few feet of the observer).
• Information Ordering - The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
• Speech Clarity - The ability to speak clearly so others can understand you.

What Validation Engineers Should Be Interested In

• Investigative - Investigative occupations frequently involve working with ideas, and require an extensive amount of thinking. These occupations can involve searching for facts and figuring out problems mentally.
• Realistic - Realistic occupations frequently involve work activities that include practical, hands-on problems and solutions. They often deal with plants, animals, and real-world materials like wood, tools, and machinery. Many of the occupations require working outside, and do not involve a lot of paperwork or working closely with others.

What Validation Engineers Need to Learn

• Engineering and Technology - Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
• Production and Processing - Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
• Mathematics - Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
• English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
• Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
• Design - Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.
• Mechanical - Knowledge of machines and tools, including their designs, uses, repair, and maintenance.
• Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.