Example Career: Validation Engineers
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.