Validation Engineers

• 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.

• 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.
• Speaking - Talking to others to convey information effectively.
• Writing - Communicating effectively in writing as appropriate for the needs of the audience.
• Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• 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.
• Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.
• Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.

Source: O*NET OnLine information for Validation Engineers.