VALIDATION ENGINEER

Job Definition:

Job Description:

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

Duties and Tasks:

• 1) Design validation study features, such as sampling, testing, or analytical methodologies.
• 2) Direct validation activities, such as protocol creation or testing.
• 3) Draw samples of raw materials, or intermediate and finished products for validation testing.
• 4) Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
• 5) Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
• 6) Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
• 7) Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
• 8) Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
• 9) Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
• 10) Identify deviations from established product or process standards and provide recommendations for resolving deviations.
• 11) Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
• 12) Procure or devise automated lab validation test stations or other test fixtures and equipment.
• 13) Resolve testing problems by modifying testing methods or revising test objectives and standards.
• 14) Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
• 15) Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
• 16) Communicate with regulatory agencies regarding compliance documentation or validation results.
• 17) Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• 18) Maintain validation test equipment.
• 19) Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
• 20) Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
• 21) Plan or conduct validation testing of alternative energy products, such as synthetic jet fuels or energy storage systems, such as fuel cells.
• 22) Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.

Activities:

• 1) 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.
• 2) Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
• 3) Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
• 4) Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
• 5) Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
• 6) Monitor Processes, Materials, or Surroundings — Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
• 7) Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
• 8) Interacting With Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
• 9) Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.
• 10) Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
• 11) Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used.
• 12) Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.
• 13) Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.
• 14) Inspecting Equipment, Structures, or Material — Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.
• 15) Judging the Qualities of Things, Services, or People — Assessing the value, importance, or quality of things or people.
• 16) Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.
• 17) Developing and Building Teams — Encouraging and building mutual trust, respect, and cooperation among team members.
• 18) 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.
• 19) Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them.
• 20) Thinking Creatively — Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
• 21) 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.
• 22) Provide Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
• 23) Coordinating the Work and Activities of Others — Getting members of a group to work together to accomplish tasks.
• 24) Guiding, Directing, and Motivating Subordinates — Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
• 25) Scheduling Work and Activities — Scheduling events, programs, and activities, as well as the work of others.
• 26) Resolving Conflicts and Negotiating with Others — Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
• 27) Training and Teaching Others — Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.

Abilities:

• 1) Written Comprehension — The ability to read and understand information and ideas presented in writing.
• 2) Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
• 3) Written Expression — The ability to communicate information and ideas in writing so others will understand.
• 4) Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
• 5) Oral Expression — The ability to communicate information and ideas in speaking so others will understand.
• 6) Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
• 7) Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
• 8) Category Flexibility — The ability to generate or use different sets of rules for combining or grouping things in different ways.
• 9) Near Vision — The ability to see details at close range (within a few feet of the observer).
• 10) Speech Recognition — The ability to identify and understand the speech of another person.
• 11) Speech Clarity — The ability to speak clearly so others can understand you.
• 12) Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
• 13) Mathematical Reasoning — The ability to choose the right mathematical methods or formulas to solve a problem.
• 14) Selective Attention — The ability to concentrate on a task over a period of time without being distracted.

Knowledge:

• 1) 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.
• 2) Production and Processing — Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
• 3) Mathematics — Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
• 4) English Language — Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
• 5) Computers and Electronics — Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.