Senior Validation Specialist

1 week ago


Galway, Galway, Ireland beBeeValidation Full time €60,000 - €80,000

Role Overview

The primary objective of this QA Validation Engineer position is to oversee the development and maintenance of a comprehensive site validation program for an esteemed client.

Key Responsibilities:

  • Coordinate, direct and participate in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards.
  • Generate, maintain and execute Site Validation Master Plans, Project Validation Plans and schedules.
  • Develop and finalize reports, investigations and implementation of corrective actions to cGMP standards.
  • Maintain and track validation equipment, document activities in line with cGMP requirements and ensure overall cGMP compliance of production areas.

Candidates should possess a Bachelor's degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline, coupled with over 3 years' experience in Validation Engineering.

Essential Skills:

  • Excellent collaboration and communication skills
  • Strong attention to detail
  • Thorough understanding of validation concepts and documentation
  • Able to solve complex technical & equipment qualification challenges using a rational scientific approach

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