Validation Engineer

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

Validation Engineer

Varies

estimated salary

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".
  • Read More
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.
  • Read More
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.
  • Read More