Validation Engineers

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

Median Annual Wage: $94,240

Education: Bachelor's degree (76%); Post-baccalaureate certificate (17%); Post-secondary certificate (3%)

Projected Growth: Slower than average (3% to 7%)

Related Job Titles: Quality Engineer; Quality Director; Corporate Quality Engineer; Corporate Quality Manager; Quality and Reliability Engineer; Quality Assurance Engineer; Quality Coordinator; Quality Specialist; Supplier Quality Engineer; Validation Specialist

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Source: O*NET OnLine information for Validation Engineers.

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  • 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.

Source: O*NET OnLine information for Validation Engineers.

  • 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.
  • 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.
  • 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.

Source: O*NET OnLine information for Validation Engineers.

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