Validation Engineers
Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
Also Known As:
Corporate Quality Engineer
Product Quality Engineer
Quality Assurance Engineer
Quality Engineer
Quality Management Systems Engineer
Reliability Engineer
Supplier Quality Engineer
Validation Specialist
Wages
Annual wages for Validation Engineers in United States
Job Outlook
Bright
New job opportunities are very likely in the future
United States
2033 Projected Employment
377,500
12% Change From 2023
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Tasks you might complete in a day.
- Communicate with regulatory agencies regarding compliance documentation or validation results.
- Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
- Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
- Recommend resolution of identified deviations from established product or process standards.
- Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
- Direct validation activities, such as protocol creation or testing.
- Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
- Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
- Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
- Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
- Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.
- Design validation study features, such as sampling, testing, or analytical methodologies.
- Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
- Resolve testing problems by modifying testing methods or revising test objectives and standards.
- Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
- Recommend resolution of identified deviations from established product or process standards.
- Draw samples of raw materials, intermediate products, or finished products for validation testing.
- Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
- Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
- Study product characteristics or customer requirements to determine validation objectives and standards.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Devise automated lab validation test stations or other test fixtures or equipment.
- Maintain validation test equipment.
Subject areas you may need to master.
- Personnel and Human Resources - Knowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems.
- Mathematics - Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
- Law and Government - Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
- Food Production - Knowledge of techniques and equipment for planting, growing, and harvesting food products (both plant and animal) for consumption, including storage/handling techniques.
- Mechanical - Knowledge of machines and tools, including their designs, uses, repair, and maintenance.
- Geography - Knowledge of principles and methods for describing the features of land, sea, and air masses, including their physical characteristics, locations, interrelationships, and distribution of plant, animal, and human life.
- Medicine and Dentistry - Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
- Foreign Language - Knowledge of the structure and content of a foreign (non-English) language including the meaning and spelling of words, rules of composition and grammar, and pronunciation.
- Fine Arts - Knowledge of the theory and techniques required to compose, produce, and perform works of music, dance, visual arts, drama, and sculpture.
- Philosophy and Theology - Knowledge of different philosophical systems and religions. This includes their basic principles, values, ethics, ways of thinking, customs, practices, and their impact on human culture.
- Design - Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.
- Sociology and Anthropology - Knowledge of group behavior and dynamics, societal trends and influences, human migrations, ethnicity, cultures, and their history and origins.
- Education and Training - Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
- Administrative - Knowledge of administrative and office procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and workplace terminology.
- 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.
- Psychology - Knowledge of human behavior and performance; individual differences in ability, personality, and interests; learning and motivation; psychological research methods; and the assessment and treatment of behavioral and affective disorders.
- Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
- Building and Construction - Knowledge of materials, methods, and the tools involved in the construction or repair of houses, buildings, or other structures such as highways and roads.
- English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
- History and Archeology - Knowledge of historical events and their causes, indicators, and effects on civilizations and cultures.
- Public Safety and Security - Knowledge of relevant equipment, policies, procedures, and strategies to promote effective local, state, or national security operations for the protection of people, data, property, and institutions.
- Communications and Media - Knowledge of media production, communication, and dissemination techniques and methods. This includes alternative ways to inform and entertain via written, oral, and visual media.
- 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.
- Sales and Marketing - Knowledge of principles and methods for showing, promoting, and selling products or services. This includes marketing strategy and tactics, product demonstration, sales techniques, and sales control systems.
- Transportation - Knowledge of principles and methods for moving people or goods by air, rail, sea, or road, including the relative costs and benefits.
- Production and Processing - Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
- Physics - Knowledge and prediction of physical principles, laws, their interrelationships, and applications to understanding fluid, material, and atmospheric dynamics, and mechanical, electrical, atomic and sub-atomic structures and processes.
- Chemistry - Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
- Therapy and Counseling - Knowledge of principles, methods, and procedures for diagnosis, treatment, and rehabilitation of physical and mental dysfunctions, and for career counseling and guidance.
- Telecommunications - Knowledge of transmission, broadcasting, switching, control, and operation of telecommunications systems.
- Economics and Accounting - Knowledge of economic and accounting principles and practices, the financial markets, banking, and the analysis and reporting of financial data.
- Administration and Management - Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
- Biology - Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Strengths you may need in this role.
- Monitoring - Keeping track of how well people and/or groups are doing in order to make improvements.
- Coordination - Changing what is done based on other people's actions.
- Equipment Selection - Deciding what kind of tools and equipment are needed to do a job.
- Active Learning - Figuring out how to use new ideas or things.
- Science - Using scientific rules and strategies to solve problems.
- Negotiation - Bringing people together to solve differences.
- Writing - Writing things for co-workers or customers.
- Learning Strategies - Using the best training or teaching strategies for learning new things.
- Operations Analysis - Figuring out what a product or service needs to be able to do.
- Operation and Control - Using equipment or systems.
- Judgment and Decision Making - Thinking about the pros and cons of different options and picking the best one.
- Equipment Maintenance - Planning and doing the basic maintenance on equipment.
- Quality Control Analysis - Testing how well a product or service works.
- Troubleshooting - Figuring out what is causing equipment, machines, wiring, or computer programs to not work.
- Management of Material Resources - Managing equipment and materials.
- Active Listening - Listening to others, not interrupting, and asking good questions.
- Time Management - Managing your time and the time of other people.
- Service Orientation - Looking for ways to help people.
- Persuasion - Talking people into changing their minds or their behavior.
- Installation - Installing equipment, machines, wiring, or computer programs.
- Systems Evaluation - Measuring how well a system is working and how to improve it.
- Social Perceptiveness - Understanding people's reactions.
- Technology Design - Making equipment and technology useful for customers.
- Reading Comprehension - Reading work-related information.
- Complex Problem Solving - Noticing a problem and figuring out the best way to solve it.
- Mathematics - Using math to solve problems.
- Critical Thinking - Thinking about the pros and cons of different ways to solve a problem.
- Operations Monitoring - Watching gauges, dials, or display screens to make sure a machine is working.
- Instructing - Teaching people how to do something.
- Programming - Writing computer programs.
- Speaking - Talking to others.
- Repairing - Repairing machines or systems using the right tools.
- Management of Personnel Resources - Selecting and managing the best workers for a job.
- Systems Analysis - Figuring out how a system should work and how changes in the future will affect it.
- Management of Financial Resources - Making spending decisions and keeping track of what is spent.
- Category Flexibility - Grouping things in different ways.
- Perceptual Speed - Quickly comparing groups of letters, numbers, pictures, or other things.
- Manual Dexterity - Holding or moving items with your hands.
- Originality - Creating new and original ideas.
- Mathematical Reasoning - Choosing the right type of math to solve a problem.
- Spatial Orientation - Knowing where things are around you.
- Deductive Reasoning - Using rules to solve problems.
- Trunk Strength - Using your lower back and stomach.
- Speed of Limb Movement - Quickly moving your arms and legs.
- Extent Flexibility - Bending, stretching, twisting, or reaching with your body, arms, and/or legs.
- Wrist-Finger Speed - Making fast, simple, repeated movements of your fingers, hands, and wrists.
- Inductive Reasoning - Making general rules or coming up with answers from lots of detailed information.
- Time Sharing - Doing two or more things at the same time.
- Gross Body Coordination - Moving your arms, legs, and mid-section together while your whole body is moving.
- Sound Localization - Noticing the direction that a sound came from.
- Speed of Closure - Quickly knowing what you are looking at.
- Arm-Hand Steadiness - Keeping your arm or hand steady.
- Oral Comprehension - Listening and understanding what people say.
- Problem Sensitivity - Noticing when problems happen.
- Near Vision - Seeing details up close.
- Depth Perception - Deciding which thing is closer or farther away from you, or deciding how far away it is from you.
- Fluency of Ideas - Coming up with lots of ideas.
- Visualization - Imagining how something will look after it is moved around or changed.
- Response Orientation - Quickly deciding if you should move your hand, foot, or other body part.
- Stamina - Exercising for a long time without getting out of breath.
- Static Strength - Lifting, pushing, pulling, or carrying.
- Oral Expression - Communicating by speaking.
- Written Comprehension - Reading and understanding what is written.
- Multilimb Coordination - Using your arms and/or legs together while sitting, standing, or lying down.
- Dynamic Strength - Exercising for a long time without your muscles getting tired.
- Reaction Time - Quickly moving your hand, finger, or foot based on a sound, light, picture or other command.
- Night Vision - Seeing at night or under low light.
- Visual Color Discrimination - Noticing the difference between colors, including shades and brightness.
- Hearing Sensitivity - Telling the difference between sounds.
- Speech Clarity - Speaking clearly.
- Peripheral Vision - Seeing something to your side when your are looking ahead.
- Speech Recognition - Recognizing spoken words.
- Far Vision - Seeing details that are far away.
- Auditory Attention - Paying attention to one sound while there are other distracting sounds.
- Glare Sensitivity - Seeing something even if there is a glare or very bright light.
- Information Ordering - Ordering or arranging things.
- Finger Dexterity - Putting together small parts with your fingers.
- Memorization - Remembering words, numbers, pictures, or steps.
- Selective Attention - Paying attention to something without being distracted.
- Number Facility - Adding, subtracting, multiplying, or dividing.
- Control Precision - Quickly changing the controls of a machine, car, truck or boat.
- Rate Control - Changing when and how fast you move based on how something else is moving.
- Gross Body Equilibrium - Keeping your balance or staying upright.
- Dynamic Flexibility - Quickly and repeatedly bending, stretching, twisting, or reaching out with your body, arms, and/or legs.
- Written Expression - Communicating by writing.
- Flexibility of Closure - Seeing hidden patterns.
- Explosive Strength - Jumping, sprinting, or throwing something.
Average Education Attained
Highest level of education earned by people in this career.
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Content sourced from United States Department of Labor Employment and Training Administration ("DOLETA") and the Minnesota Department of Employment & Economic Development ("DEED")