Validation Engineer

Also called: Corporate Quality Engineer, Equipment Engineer, Equipment Validation Engineer, Equipment Validation Specialist, Process Development Engineer

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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.

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

Work Context

Electronic Mail — 90% responded "Every day".
Face-to-Face Discussions — 85% responded "Every day".
Importance of Being Exact or Accurate — 65% responded "Extremely important".
Indoors, Environmentally Controlled — 75% responded "Every day".
Work With Work Group or Team — 50% responded "Extremely important".
Telephone — 53% responded "Every day".
Freedom to Make Decisions — 50% responded "Some freedom".

Contact With Others — 40% responded "Contact with others most of the time".

Structured versus Unstructured Work — 60% responded "Some freedom".

Time Pressure — 50% responded "Once a week or more but not every day".

Spend Time Sitting — 35% responded "More than half the time".

Impact of Decisions on Co-workers or Company Results — 35% responded "Important results".

Importance of Repeating Same Tasks — 35% responded "Very important".

Coordinate or Lead Others — 40% responded "Important".

Physical Proximity — 50% responded "Slightly close (e.g., shared office)".

Letters and Memos — 30% responded "Once a week or more but not every day".

Deal With External Customers — 30% responded "Very important".

Frequency of Decision Making — 35% responded "Once a year or more but not every month".

Wear Common Protective or Safety Equipment such as Safety Shoes, Glasses, Gloves, Hearing Protection, Hard Hats, or Life Jackets — 30% responded "Once a year or more but not every month".

Frequency of Conflict Situations — 45% responded "Once a month or more but not every week".

Responsibility for Outcomes and Results — 45% responded "Moderate responsibility".

Sounds, Noise Levels Are Distracting or Uncomfortable — 25% responded "Once a year or more but not every month".

Work Activities

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.
Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.
Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

Interacting With Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.

Monitor Processes, Materials, or Surroundings — Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.

Inspecting Equipment, Structures, or Material — Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.

Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used.

Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.

Judging the Qualities of Things, Services, or People — Assessing the value, importance, or quality of things or people.

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.

Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.

Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.

Provide Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.

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.

Developing and Building Teams — Encouraging and building mutual trust, respect, and cooperation among team members.

Resolving Conflicts and Negotiating with Others — Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.

Training and Teaching Others — Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.

Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them.

Scheduling Work and Activities — Scheduling events, programs, and activities, as well as the work of others.

Coaching and Developing Others — Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.

Coordinating the Work and Activities of Others — Getting members of a group to work together to accomplish tasks.

Detailed Work Activities

Conduct validation tests of equipment or processes.
Devise research or testing protocols.
Prepare detailed work plans.
Devise research or testing protocols.
Analyze test or validation data.
Inspect operational processes.

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.

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.

Writing

Communicating effectively in writing as appropriate for the needs of the audience.

Monitoring

Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

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.

Complex Problem Solving

Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.

Science

Using scientific rules and methods to solve problems.

Active Learning

Understanding the implications of new information for both current and future problem-solving and decision-making.

Systems Evaluation

Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.

Judgment and Decision Making

Considering the relative costs and benefits of potential actions to choose the most appropriate one.

Operation Monitoring

Watching gauges, dials, or other indicators to make sure a machine is working properly.

Systems Analysis

Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.

Social Perceptiveness

Being aware of others' reactions and understanding why they react as they do.

Mathematics

Using mathematics to solve problems.

Operations Analysis

Analyzing needs and product requirements to create a design.

Coordination

Adjusting actions in relation to others' actions.

Quality Control Analysis

Conducting tests and inspections of products, services, or processes to evaluate quality or performance.

Learning Strategies

Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.

Time Management

Managing one's own time and the time of others.

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.

Deductive Reasoning

The ability to apply general rules to specific problems to produce answers that make sense.

Oral Comprehension

The ability to listen to and understand information and ideas presented through spoken words and sentences.

Oral Expression

The ability to communicate information and ideas in speaking so others will understand.

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.

Inductive Reasoning

The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).

Near Vision

The ability to see details at close range (within a few feet of the observer).

Category Flexibility

The ability to generate or use different sets of rules for combining or grouping things in different ways.

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).

Speech Clarity

The ability to speak clearly so others can understand you.

Speech Recognition

The ability to identify and understand the speech of another person.

Mathematical Reasoning

The ability to choose the right mathematical methods or formulas to solve a problem.

Number Facility

The ability to add, subtract, multiply, or divide quickly and correctly.

Fluency of Ideas

The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity).

Originality

The ability to come up with unusual or clever ideas about a given topic or situation, or to develop creative ways to solve a problem.

Flexibility of Closure

The ability to identify or detect a known pattern (a figure, object, word, or sound) that is hidden in other distracting material.

Perceptual Speed

The ability to quickly and accurately compare similarities and differences among sets of letters, numbers, objects, pictures, or patterns. The things to be compared may be presented at the same time or one after the other. This ability also includes comparing a presented object with a remembered object.

Selective Attention