Summary Report for:
17-2199.02 - Validation Engineers
Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
Sample of reported job titles: Corporate Quality Engineer, Corporate Quality Manager, Quality and Reliability Engineer, Quality Assurance Engineer, Quality Coordinator, Quality Director, Quality Engineer, Quality Specialist, Supplier Quality Engineer, Validation Specialist
Tasks | Tools & Technology | Knowledge | Skills | Abilities | Work Activities | Detailed Work Activities | Work Context | Job Zone | Education | Credentials | Interests | Work Styles | Work Values | Related Occupations | Wages & Employment | Job Openings
- 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 pharmaceutical, electronics, or other types of production.
- 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.
- Plan or conduct validation testing of alternative energy products, such as synthetic jet fuels or energy storage systems, such as fuel cells.
- Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.
Tools & Technology
Tools used in this occupation:
- Flow sensors
- Frequency analyzers — Spectrum analyzers
- Gel documentation systems — Gel electrophoresis systems
- Integrated circuit testers — In-target probes ITP; Logic analyzers
- Microcontrollers — Programmable logic controllers PLC
- Network analyzers — Network protocol analyzers; Tektronix Communications Network & Service Analyzer NSA
- Pressure sensors
- Protocol analyzers
- Thermal conductivity analyzers — Thermal validation systems
Technology used in this occupation:
- Analytical or scientific software — Cadence Incisive Enterprise Specman Elite Testbench; IndySoft Gage InSite Enterprise; QUALCOMM eXtensible Diagnostic Monitor QxDM; The MathWorks MATLAB (see all 12 examples)
- Compliance software — Sparta Systems Trackwise
- Data base user interface and query software — Microsoft Access
- Development environment software — C; National Instruments LabVIEW; Verilog; Very high speed integrated circuit VHSIC hardware definition language VHDL (see all 5 examples)
- Document management software — EMC Documentum
- Electronic mail software — Email software; IBM Lotus Notes; Microsoft Outlook
- File versioning software — Apache Subversion *; Git *
- Industrial control software — GE Intelligent Platforms Proficy HMI/SCADA iFIX
- Object or component oriented development software — C++; Microsoft Visual C#; Practical extraction and reporting language Perl; Python
- Operating system software — Microsoft Windows; Shell script; UNIX
- Presentation software — Microsoft PowerPoint
- Program testing software — Bugzilla *; Hewlett Packard QuickTest Professional; Windows kernel debuggers
- Project management software — Microsoft Project
- Spreadsheet software — Microsoft Excel
- Word processing software — Microsoft Word
* Software developed by a government agency and/or distributed as freeware or shareware.
- 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.
- 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.
- Clerical — Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
- Active Listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
- Reading Comprehension — Understanding written sentences and paragraphs in work related documents.
- Science — Using scientific rules and methods to solve problems.
- Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
- Speaking — Talking to others to convey information effectively.
- Writing — Communicating effectively in writing as appropriate for the needs of the audience.
- Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
- Monitoring — Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
- Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making.
- Coordination — Adjusting actions in relation to others' actions.
- Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.
- Operations Analysis — Analyzing needs and product requirements to create a design.
- Social Perceptiveness — Being aware of others' reactions and understanding why they react as they do.
- Systems Analysis — Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
- Time Management — Managing one's own time and the time of others.
- Mathematics — Using mathematics to solve problems.
- Operation Monitoring — Watching gauges, dials, or other indicators to make sure a machine is working properly.
- Systems Evaluation — Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
- 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.
- Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
- 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.
- Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
- 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.
- 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.
- Speech Recognition — The ability to identify and understand the speech of another person.
- Mathematical Reasoning — The ability to choose the right mathematical methods or formulas to solve a problem.
- Selective Attention — The ability to concentrate on a task over a period of time without being distracted.
- Fluency of Ideas — The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity).
- Number Facility — The ability to add, subtract, multiply, or divide quickly and correctly.
- Originality — The ability to come up with unusual or clever ideas about a given topic or situation, or to develop creative ways to solve a problem.
- Perceptual Speed — The ability to quickly and accurately compare similarities and differences among sets of letters, numbers, objects, pictures, or patterns. The things to be compared may be presented at the same time or one after the other. This ability also includes comparing a presented object with a remembered object.
- Time Sharing — The ability to shift back and forth between two or more activities or sources of information (such as speech, sounds, touch, or other sources).
- Evaluating Information to Determine Compliance with Standards — Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
- Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
- Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
- Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
- Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
- Monitor Processes, Materials, or Surroundings — Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
- Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
- Interacting With Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
- Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.
- Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
- Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used.
- Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.
- Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.
- Inspecting Equipment, Structures, or Material — Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.
- Judging the Qualities of Things, Services, or People — Assessing the value, importance, or quality of things or people.
- Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.
- Developing and Building Teams — Encouraging and building mutual trust, respect, and cooperation among team members.
- Communicating with Persons Outside Organization — Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
- Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them.
- Estimating the Quantifiable Characteristics of Products, Events, or Information — Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.
- Provide Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
- Thinking Creatively — Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
- Coordinating the Work and Activities of Others — Getting members of a group to work together to accomplish tasks.
- Guiding, Directing, and Motivating Subordinates — Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
- Scheduling Work and Activities — Scheduling events, programs, and activities, as well as the work of others.
- Resolving Conflicts and Negotiating with Others — Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
- Training and Teaching Others — Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
Detailed Work Activities
- Operate computer systems.
- Update technical knowledge.
- Document technical design details.
- Prepare detailed work plans.
- Review technical documents to plan work.
- Inspect finished products to locate flaws.
- Recommend technical design or process changes to improve efficiency, quality, or performance.
- Maintain test equipment.
- Analyze test or validation data.
- Resolve operational performance problems.
- Design electronic or computer equipment or instrumentation.
- Maintain operational records or records systems.
- Train personnel on proper operational procedures.
- Devise research or testing protocols.
- Purchase materials, equipment, or other resources.
- Direct quality control activities.
- Collect samples of raw materials or finished products.
- Communicate technical information to suppliers, contractors, or regulatory agencies.
- Conduct validation tests of equipment or processes.
- Inspect operational processes.
- Electronic Mail — 97% responded “Every day.”
- Face-to-Face Discussions — 90% responded “Every day.”
- Telephone — 83% responded “Every day.”
- Indoors, Environmentally Controlled — 76% responded “Every day.”
- Duration of Typical Work Week — 75% responded “More than 40 hours.”
- Importance of Being Exact or Accurate — 59% responded “Extremely important.”
- Work With Work Group or Team — 45% responded “Very important.”
- Contact With Others — 52% responded “Contact with others most of the time.”
- Structured versus Unstructured Work — 38% responded “A lot of freedom.”
- Time Pressure — 55% responded “Once a week or more but not every day.”
- Freedom to Make Decisions — 52% responded “Some freedom.”
- Impact of Decisions on Co-workers or Company Results — 52% responded “Important results.”
- Spend Time Sitting — 55% responded “More than half the time.”
- Coordinate or Lead Others — 48% responded “Very important.”
- Letters and Memos — 43% responded “Once a week or more but not every day.”
- Frequency of Decision Making — 31% responded “Every day.”
- Wear Common Protective or Safety Equipment such as Safety Shoes, Glasses, Gloves, Hearing Protection, Hard Hats, or Life Jackets — 28% responded “Every day.”
- Frequency of Conflict Situations — 48% responded “Once a month or more but not every week.”
- Responsibility for Outcomes and Results — 45% responded “Moderate responsibility.”
- Importance of Repeating Same Tasks — 28% responded “Important.”
- Physical Proximity — 59% responded “Slightly close (e.g., shared office).”
- Level of Competition — 52% responded “Moderately competitive.”
|Title||Job Zone Four: Considerable Preparation Needed|
|Education||Most of these occupations require a four-year bachelor's degree, but some do not.|
|Related Experience||A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.|
|Job Training||Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.|
|Job Zone Examples||Many of these occupations involve coordinating, supervising, managing, or training others. Examples include accountants, sales managers, database administrators, teachers, chemists, art directors, and cost estimators.|
|SVP Range||(7.0 to < 8.0)|
Percentage of Respondents
|Education Level Required|
This occupation may require a background in the following science, technology, engineering, and mathematics (STEM) educational disciplines:
Interest code: IRC
- 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.
- Conventional — Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
- Integrity — Job requires being honest and ethical.
- Attention to Detail — Job requires being careful about detail and thorough in completing work tasks.
- Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems.
- Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations.
- Cooperation — Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
- Initiative — Job requires a willingness to take on responsibilities and challenges.
- Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high stress situations.
- Persistence — Job requires persistence in the face of obstacles.
- Self Control — Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations.
- Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace.
- Achievement/Effort — Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.
- Leadership — Job requires a willingness to lead, take charge, and offer opinions and direction.
- Independence — Job requires developing one's own ways of doing things, guiding oneself with little or no supervision, and depending on oneself to get things done.
- Innovation — Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems.
- Concern for Others — Job requires being sensitive to others' needs and feelings and being understanding and helpful on the job.
- Working Conditions — Occupations that satisfy this work value offer job security and good working conditions. Corresponding needs are Activity, Compensation, Independence, Security, Variety and Working Conditions.
- Achievement — Occupations that satisfy this work value are results oriented and allow employees to use their strongest abilities, giving them a feeling of accomplishment. Corresponding needs are Ability Utilization and Achievement.
- Independence — Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy.
Wages & Employment Trends
Median wages data collected from Engineers, All Other.
Employment data collected from Engineers, All Other.
Industry data collected from Engineers, All Other.
|Median wages (2014)||$45.31 hourly, $94,240 annual|
|Employment (2012)||133,000 employees|
|Projected growth (2012-2022)||Slower than average (3% to 7%)|
|Projected job openings (2012-2022)||29,500|
|Top industries (2012)|
Source: Bureau of Labor Statistics 2014 wage data and 2012-2022 employment projections . "Projected growth" represents the estimated change in total employment over the projections period (2012-2022). "Projected job openings" represent openings due to growth and replacement.