Validation Engineer Career

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


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Validation Engineer Career

What Validation Engineers do:

  • 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.
  • Identify deviations from established product or process standards and provide recommendations for resolving deviations.
  • Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
  • Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
  • Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
  • Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
  • Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
  • Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
  • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
  • Design validation study features, such as sampling, testing, or analytical methodologies.
  • Draw samples of raw materials, or intermediate and finished products for validation testing.
  • Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
  • 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.
  • Direct validation activities, such as protocol creation or testing.
  • Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
  • Procure or devise automated lab validation test stations or other test fixtures and equipment.
  • Communicate with regulatory agencies regarding compliance documentation or validation results.
  • Maintain validation test equipment.

What work activities are most important?

Importance 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.

Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.

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

Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

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

Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.

Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.

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

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

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

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

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

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

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

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

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.

Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.

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

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

Guiding, Directing, and Motivating Subordinates - Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.

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

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.

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.

Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.

Selling or Influencing Others - Convincing others to buy merchandise/goods or to otherwise change their minds or actions.

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

Monitoring and Controlling Resources - Monitoring and controlling resources and overseeing the spending of money.

Controlling Machines and Processes - Using either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles).

Holland Code Chart for a Validation Engineer

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