Validation Engineers

What they do:

Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.

On the job, you would:

  • 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 pharmaceutical, electronics, or other types of production.
  • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
  • Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
  • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
  • Direct validation activities, such as protocol creation or testing.
  • Draw samples of raw materials, or intermediate and finished products for validation testing.
  • Identify deviations from established product or process standards and provide recommendations for resolving deviations.

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.
  • 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.

Skills

  • Reading Comprehension
  • Understanding written sentences and paragraphs in work related documents.
  • 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.
  • 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.
  • Writing
  • Communicating effectively in writing as appropriate for the needs of the audience.
  • Speaking
  • Talking to others to convey information effectively.
  • Monitoring
  • Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
  • Complex Problem Solving
  • Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
  • Coordination
  • Adjusting actions in relation to others' actions.
  • Active Learning
  • Understanding the implications of new information for both current and future problem-solving and decision-making.

Abilities

  • 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.
  • 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).

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.
  • Communicating with Supervisors, Peers, or Subordinates
  • Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
  • 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.

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.
  • Third Interest High-Point
  • Tertiary-Cutoff/Rank Descriptiveness
  • 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.
  • Enterprising
  • Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.
  • Artistic
  • Artistic occupations frequently involve working with forms, designs and patterns. They often require self-expression and the work can be done without following a clear set of rules.
  • First Interest High-Point
  • Primary-Rank Descriptiveness
  • Social
  • Social occupations frequently involve working with, communicating with, and teaching people. These occupations often involve helping or providing service to others.
  • Second Interest High-Point
  • Secondary-Cutoff/Rank Descriptiveness

Work Styles

  • 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.
  • Stress Tolerance
  • Job requires accepting criticism and dealing calmly and effectively with high stress situations.
  • Initiative
  • Job requires a willingness to take on responsibilities and challenges.
  • 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.