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Careers / Validation Engineers |
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Summary Description |
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Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements. |
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Sample Job Titles |
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1. |
Corporate Quality Engineer |
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2. |
Corporate Quality Manager |
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3. |
Equipment Engineer |
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4. |
Equipment Validation Engineer |
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5. |
Equipment Validation Specialist |
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6. |
Process Development Engineer |
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7. |
Process Engineer |
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8. |
Qualification Engineer |
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Quality and Reliability Engineer |
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10. |
Quality Assurance Engineer |
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11. |
Quality Control Engineer |
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12. |
Quality Coordinator |
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13. |
Quality Director |
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14. |
Quality Engineer |
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15. |
Quality Specialist |
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16. |
Reliability Engineer |
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17. |
Site Reliability Engineer |
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18. |
Supplier Quality Engineer |
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19. |
System Validation Engineer |
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20. |
Validation Engineer |
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21. |
Validation Specialist |
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Job Tasks |
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Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Analyze test or validation data.
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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.
- Devise research or testing protocols.
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Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
- Direct quality control activities.
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Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
- Review technical documents to plan work.
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Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
- Operate computer systems.
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Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
- Maintain operational records or records systems.
- Document technical design details.
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Resolve testing problems by modifying testing methods or revising test objectives and standards.
- Resolve operational performance problems.
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Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
- Document technical design details.
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Identify deviations from established product or process standards and provide recommendations for resolving deviations.
- Inspect finished products to locate flaws.
- Recommend technical design or process changes to improve efficiency, quality, or performance.
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Direct validation activities, such as protocol creation or testing.
- Direct quality control activities.
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Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
- Prepare detailed work plans.
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Communicate with regulatory agencies regarding compliance documentation or validation results.
- Communicate technical information to suppliers, contractors, or regulatory agencies.
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Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
- Conduct validation tests of equipment or processes.
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Design validation study features, such as sampling, testing, or analytical methodologies.
- Devise research or testing protocols.
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Maintain validation test equipment.
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Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
- Update technical knowledge.
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Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
- Inspect operational processes.
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Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
- Train personnel on proper operational procedures.
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Draw samples of raw materials, or intermediate and finished products for validation testing.
- Collect samples of raw materials or finished products.
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Procure or devise automated lab validation test stations or other test fixtures and equipment.
- Design electronic or computer equipment or instrumentation.
- Purchase materials, equipment, or other resources.
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Work Activities |
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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. |
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Communicating with Supervisors, Peers, or Subordinates —
Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person. |
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Getting Information —
Observing, receiving, and otherwise obtaining information from all relevant sources. |
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Analyzing Data or Information —
Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts. |
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Identifying Objects, Actions, and Events —
Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events. |
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Monitor Processes, Materials, or Surroundings —
Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems. |
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Processing Information —
Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data. |
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Interacting With Computers —
Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information. |
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Making Decisions and Solving Problems —
Analyzing information and evaluating results to choose the best solution and solve problems. |
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Documenting/Recording Information —
Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form. |
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Interpreting the Meaning of Information for Others —
Translating or explaining what information means and how it can be used. |
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Organizing, Planning, and Prioritizing Work —
Developing specific goals and plans to prioritize, organize, and accomplish your work. |
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Updating and Using Relevant Knowledge —
Keeping up-to-date technically and applying new knowledge to your job. |
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Inspecting Equipment, Structures, or Material —
Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects. |
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Judging the Qualities of Things, Services, or People —
Assessing the value, importance, or quality of things or people. |
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Establishing and Maintaining Interpersonal Relationships —
Developing constructive and cooperative working relationships with others, and maintaining them over time. |
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Developing and Building Teams —
Encouraging and building mutual trust, respect, and cooperation among team members. |
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Developing Objectives and Strategies —
Establishing long-range objectives and specifying the strategies and actions to achieve them. |
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Communicating with Persons Outside Organization —
Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail. |
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Estimating the Quantifiable Characteristics of Products, Events, or Information —
Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity. |
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Thinking Creatively —
Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions. |
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Provide Consultation and Advice to Others —
Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics. |
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Coordinating the Work and Activities of Others —
Getting members of a group to work together to accomplish tasks. |
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Scheduling Work and Activities —
Scheduling events, programs, and activities, as well as the work of others. |
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Guiding, Directing, and Motivating Subordinates —
Providing guidance and direction to subordinates, including setting performance standards and monitoring performance. |
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Resolving Conflicts and Negotiating with Others —
Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others. |
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Training and Teaching Others —
Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others. |
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Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment —
Providing documentation, detailed instructions, drawings, or specifications to tell others about how devices, parts, equipment, or structures are to be fabricated, constructed, assembled, modified, maintained, or used. |
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Performing Administrative Activities —
Performing day-to-day administrative tasks such as maintaining information files and processing paperwork. |
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Selling or Influencing Others —
Convincing others to buy merchandise/goods or to otherwise change their minds or actions. |
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Coaching and Developing Others —
Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills. |
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Monitoring and Controlling Resources —
Monitoring and controlling resources and overseeing the spending of money. |
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Controlling Machines and Processes —
Using either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles). |
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Interesting Fact |
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Danny DeVito once worked as a janitor. |
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Did you know... |
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