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Job

Validation Engineer

  • Job ref:

    11914

  • Location:

    Wilmington, United States

  • Sector:

    Quality Engineers

  • Contact:

    Lissa Jerez

  • Published:

    about 2 months ago

VALIDATION ENGINEER

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RESPONSIBILITIES:

  • Preparing validation and performance qualification protocols for manufacturing processes, systems, electronics, or other types of production.
  • Processing automated lab test stations or other test fixtures and equipment.
  • Communicating with agencies regarding compliance documentation validation results.
  • Maintaining validation test equipment
  • Determine process capability of equipment through execution if protocols; incorporating into respective operating procedures and batch records.
  • Identifying deviations from established equipment, product or process standards and provide recommendations for resolving deviations.
  • Participating in internal/external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
  • Preparing, maintaining, or reviewing validation and compliance documentation, such as engineering change notices schematics, or protocols.
  • Studying product characteristics or customer requirements and confer with management to determine validation objectives and standards.

 

Desired Skills / Experience

  • Bachelor's degree in a technical field i.e., Biology, Chemistry, Engineering and minimum
  • 8-10 years related experience and/or training; or equivalent combination of education and experience.
  • Experience in interpreting graphs, charts, engineering diagrams (P&\O), blueprints, specifications, equipment manuals and guides and other instructions to solve problems.
  • Experience writing test plans, procedures and project schedules.
  • Experience writing User Requirements, Functional Requirements, Design Specifications, FAT's, SAT's, IQ's, OQ's, PQ's.
  • Experience executing FAT's, SAT's, receipt verification, IQ, OQ, PQ.
  • Experience using scientific rules and methods to solve problems,