Ll02-020924 Senior Automation Specialist for

hace 2 semanas


Panamá, Panamá, Panamá Validation & Engineering Group A tiempo completo

_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.

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