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Validation Engineer II (Packaging)

Req ID: J2292237

  • Ubicación
    Albuquerque, Nuevo Mexico, Nuevo México, United States of America
  • Categoría Grupo de Servicios de Diseño
  • Publicado viernes, 22 de octubre de 2021
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

JOB SUMMARY
Provides validation and project support for NPI activities in the Jabil ABQ Packaging Workcell.  The successful candidate should bring experience in writing and executing IQ/OQ/PQ protocols in a regulated environment as well as knowledge of project management, configuration management, and change control.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Develop expertise with federal regulations and guidelines including 21 CFR Part 820 and ISO 13485 as applied to packaging and labeling of medical devices.
  • Interface with production staff and manufacturing engineers to determine equipment and system requirements for new packaging products and processes.
  • Interact with Plant Management, Operations, Quality, Sterilization, and Purchasing to understand requirements, communicate status, and resolve issues.
  • Manage and execute projects focused on introducing new packaging products, equipment, and processes.
  • Cooperate with strategic collaborators to write and execute validation documents (IQ, OQ, SQ, PQ, PV) that are compliant with applicable global regulations, directives, standards, and guidance requirements.
  • Work with enterprise resource systems for project management, configuration management, and change control
  • Displays awareness and compliance of Health & Safety issues
  • May perform other duties and responsibilities as assigned.

JOB QUALIFICATIONS and KNOWLEDGE REQUIREMENTS

  • Requirements for the validation of medical devices, packaging, and labeling in a 21 CFR Part 820 environment.
  • Experience working with customers and managing expectations
  • Technical writing in a regulated environment
  • Advanced PC and communications skills
  • Ability to exercise initiative and apply judgement to complete ambiguous tasks
  • Strong attention to detail and organizational skills

Education & Experience Requirements

  • Technical degree preferred
  • 3+ years of experience with validation of manufacturing processes and equipment; preferably in a regulated environment
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