Experience Requirements Overview

  • Job Zone Four: Considerable Preparation Needed
  • 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.
  • Most of these occupations require a four-year bachelor's degree, but some do not.
  • Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.

Education, Training and Experience

Required Level of Education: Bachelor's Degree

Related Work Experience: Over 2 years, up to and including 4 years

On-Site or In-Plant Training: Up to and including 1 month

On-the-Job Training: Over 6 months, up to and including 1 year

Detailed Work Activities

  • Conduct validation tests of equipment or processes.
  • Devise research or testing protocols.
  • Prepare detailed work plans.
  • Analyze test or validation data.
  • Inspect operational processes.

Work Values

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.

Working Conditions

Recognition

Relationships

Support

Independence

Tasks

  • 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.
  • Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
  • Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
  • Maintain validation test equipment.
  • Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
  • 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.
  • Recommend resolution of identified deviations from established product or process standards.
  • 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.
  • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
  • 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.
  • Draw samples of raw materials, intermediate products, or finished products for validation testing.
  • Direct validation activities, such as protocol creation or testing.
  • Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
  • Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
  • Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.
  • Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
  • Plan or conduct validation testing of alternative energy products, such as synthetic jet fuels or energy storage systems, such as fuel cells.
  • Devise automated lab validation test stations or other test fixtures or equipment.

Work Styles

Achievement/Effort

Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.

Persistence

Initiative

Leadership

Cooperation

Concern for Others

Social Orientation

Self-Control

Stress Tolerance

Adaptability/Flexibility

Dependability

Attention to Detail

Integrity

Independence

Innovation

Analytical Thinking

Data Source: This page includes information from the O*NET 28.0 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA). Used under the CC BY 4.0 license. O*NET® is a trademark of USDOL/ETA. This page includes Employment Projections program, Occupational Employment and Wage Statistics program, U.S. Bureau of Labor Statistics.