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    LL02-020924 Sr. Automation Specialist - Juana Díaz, Puerto Rico - Validation & Engineering Group, Inc

    Validation & Engineering Group, Inc
    Validation & Engineering Group, Inc Juana Díaz, Puerto Rico

    Encontrado en: Talent PR C2 - hace 6 días

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    Descripción
    Department: Field - LL Location: Juana Diaz, 075
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    Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

    We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Senior Automation Specialist for Medical Devices

    • Qualifications:

  • Bachelor's Degree in Computer Science or Engineering.
  • Minimum of 8 years of experience in direct pharmaceutical, medical device or biotechnology industries.
  • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
  • Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
  • SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
  • Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.
  • Experience in Medical Devices, Automation Controls, Design Specifications, Allen Bradley, Software Validation and Design Review.
  • Must be fully bilingual (English / Spanish) with excellent oral skills.
  • Must be proficient using MS Windows and Microsoft Office applications.
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