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Validation Engineers

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

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    Work Activities

    Work Activities

    • 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.
    • Resolve testing problems by modifying testing methods or revising test objectives and standards.
    • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
    • 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.
    • Plan or conduct validation testing of alternative energy products, such as synthetic jet fuels or energy storage systems, such as fuel cells.
    • 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.
    • Devise automated lab validation test stations or other test fixtures or equipment.

    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.

    WorkKeys®

    Applied Math
    N/A
    Workplace Documents
    N/A
    Graphic Literacy
    N/A

    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.

    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.

    Career Video

    Additional videos and more information available on CareerOneStop

    Pay

    • Ohio Annual Salary 82590/yr
    • Typical Salary
    • Ohio Hourly Wage 39.71/hr
    • Typical Hourly Wage

    Ohio Employment Trends

    • Currently Employed 15,950
    • Yearly Projected Openings 1,300

    Typical Education

    Personality

    Investigative: People interested in this work like activities that include ideas, thinking, and figuring things out. They do well at jobs that need:
    • Attention to Detail
    • Integrity
    • Dependability
    • Analytical Thinking
    • Cooperation
    • Adaptability/Flexibility

    Tools

    • Network analyzers
    • Integrated circuit testers
    • Gel documentation systems
    • Frequency analyzers
    • Flow sensors

    Technology

    • Operating system software
    • Object or component oriented development software
    • Development environment software
    • Data base management system software
    • Analytical or scientific software

    Tags

    • Bright Outlook occupations will grow rapidly in the next few years, have a large number of openings, or are new and emerging careers.
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    Workforce Supply Tool

    Workforce Supply Tool

    The Workforce Supply Tool provides statistics for the occupations in highest demand throughout Ohio.

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