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, Product Quality Engineer, Quality Assurance Engineer, Quality Engineer, Quality Management Systems Engineer, Reliability Engineer, Supplier Quality Engineer, Validation Specialist
Occupation-Specific Information
Tasks
- 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.
- Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
- Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
Technology Skills
- Analytical or scientific software:Cadence Incisive Enterprise Simulator,Cadence Incisive Enterprise Specman Elite Testbench,IndySoft Gage InSite Enterprise,Laboratory information management system LIMS,Logic simulators,Minitab,QUALCOMM eXtensible Diagnostic Monitor QxDM,Simulation program with integrated circuit emphasis SPICE,Simulation software,Statistical software,Synopsys electronic design software,The MathWorks MATLAB
- Application server software:Docker,GitHub,Red Hat WildFly
- Cloud-based management software:Splunk Enterprise
- Compliance software:Sparta Systems TrackWise
- Computer aided design CAD software:Dassault Systemes CATIA,Dassault Systemes SolidWorks,PTC Creo Parametric
Occupational Requirements
Work Activities
- 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.
- Getting Information:Observing, receiving, and otherwise obtaining information from all relevant sources.
- Documenting/Recording Information:Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
- Analyzing Data or Information:Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
- Making Decisions and Solving Problems:Analyzing information and evaluating results to choose the best solution and solve problems.
Detailed Work Activities
- Analyze test or validation data.
- Collect samples of raw materials or finished products.
- Communicate technical information to suppliers, contractors, or regulatory agencies.
- Conduct validation tests of equipment or processes.
- Design electronic or computer equipment or instrumentation.
Work Context
- Electronic Mail:89% responded"Every day"
- Face-to-Face Discussions:84% responded"Every day"
- Indoors, Environmentally Controlled:75% responded"Every day"
- Importance of Being Exact or Accurate:65% responded"Extremely important"
- Structured versus Unstructured Work:60% responded"Some freedom"
Worker Requirements
Skills
- Reading Comprehension:Understanding written sentences and paragraphs in work-related documents.
- 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.
- 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.
Knowledge
- 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.
- English Language:Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
- 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.
- Mathematics:Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
Education
How much education does a new hire need to perform a job in this occupation? Respondents said:
- 90%Bachelor's Degree
Worker Characteristics
Abilities
- Deductive Reasoning:The ability to apply general rules to specific problems to produce answers that make sense.
- Written Comprehension:The ability to read and understand information and ideas presented in writing.
- 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).
- Oral Comprehension:The ability to listen to and understand information and ideas presented through spoken words and sentences.
Interests
- 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.
Work Values
- 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.
Work Styles
- Attention to Detail:Job requires being careful about detail and thorough in completing work tasks.
- Integrity:Job requires being honest and ethical.
- Dependability:Job requires being reliable, responsible, and dependable, and fulfilling obligations.
- Analytical Thinking:Job requires analyzing information and using logic to address work-related issues and problems.
- Cooperation:Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
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