Role Description

Scientific > Validation Engineer

Salary National Average

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63450.0000 85020.0000 108930.0000

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Short Description:

A Validation Engineer is responsible for ensuring that systems, equipment, and processes meet performance standards and regulatory requirements. They design and execute validation protocols, including testing and documentation, to verify the functionality and compliance of products or systems. Validation Engineers collaborate with cross-functional teams to troubleshoot issues, improve processes, and ensure that all aspects of production adhere to quality standards. Strong problem-solving skills, knowledge of validation methodologies, and familiarity with industry regulations are essential for success in this role.

Duties / Responsibilities:

  • 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 product.
  • 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.

Skills / Requirements / Qualifications

  • Strong Analytical and Problem-Solving Skills: Ability to assess complex systems, identify issues, and apply logical thinking to resolve validation problems.
  • Knowledge of Validation Protocols and Standards: Understanding of industry-specific validation standards (e.g., FDA, ISO, GMP) and the ability to apply them in practice.
  • Experience with Software and Hardware Validation: Proficiency in validating both software (e.g., automation systems) and hardware (e.g., manufacturing equipment) to ensure they meet required standards.
  • Attention to Detail: Exceptional focus on precision and accuracy in testing, documentation, and reporting results.
  • Familiarity with Validation Tools and Techniques: Experience with validation software, testing tools, and methodologies such as IQ, OQ, PQ, and risk-based validation approaches.
  • Bachelor's Degree in Engineering or Related Field: A degree in electrical, mechanical, chemical, or industrial engineering, or a related technical field is typically required.
  • Experience in Regulatory Environments: Experience working in regulated industries such as pharmaceuticals, medical devices, or biotechnology, with knowledge of relevant guidelines.
  • Strong Communication and Documentation Skills: Ability to clearly document validation results, prepare reports, and communicate findings to internal teams or regulatory bodies.

Job Zones

  • Title:  Job Zone Four: Considerable Preparation Needed
  • Education:  Most of these occupations require a four-year bachelor's degree, but some do not.
  • Related Experience:   Most of these occupations require a four-year bachelor's degree, but some do not.
  • Job Training:  Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
  • Job Zone Examples:  Many of these occupations involve coordinating, supervising, managing, or training others. Examples include real estate brokers, sales managers, database administrators, graphic designers, chemists, art directors, and cost estimators.
  • SVP Range:  (7.0 to < 8.0)

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