Example Career: Validation Engineers

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.