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Validation Engineer

Validation Engineer

QRC Group, IncSmyrna, GA, US
1 day ago
Job type
  • Full-time
Job description

Job Description

Job Description

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http : / / www. qrcgroup.com / to learn more about our services and solutions!

Job Description

Validation Engineers to support the internal development and validation of a multi-dose preservative-free (MDPF) nozzle subsystem and any other miscellaneous project related deliverables as they arise.

Scope Includes :

  • Validation of new molding and assembly units
  • Qualification of ISO7 clean rooms
  • Integration of metrology instruments and handling systems
  • Execution of IQ / OQ / PQ protocols, FAT / SAT, and traceability documentation
  • Collaboration on a comprehensive Validation Master Plan

Location :  SouthEast, United States (Travel Required)

Qualifications

  • Bachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial)
  • Location :  SouthEast, United States (Travel Required)

    • Technical Skills

  • IQ / OQ / PQ protocol development and execution
  • FAT / SAT testing and documentation
  • Validation Master Plan (VMP) creation
  • MES / SCADA system qualification
  • Injection molding and automated assembly validation
  • Metrology equipment calibration and Gage R&R
  • Traceability Matrix development
  • Experience with KNEAT software (highly desirable)

    • Regulatory Knowledge

  • FDA 21 CFR Part 820
  • EU MDR 2017 / 745
  • ISO 13485 & ISO 14971
  • GMP compliance

    • Certifications

  • ISO 13485 Quality Management
  • ISO 14971 Risk Management
  • GMP Training
  • Six Sigma (Green or Black Belt)

    • Soft Skills

  • Strong documentation and report writing
  • Cross-functional collaboration
  • Ability to train personnel
  • Analytical thinking and problem-solving

    • Location :  SouthEast, United States (Travel Required)

    Additional Information

    All your information will be kept confidential according to EEO guidelines.

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    Validation Engineer • Smyrna, GA, US

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