Product Validation Specialist

2 days ago


Longford, Ireland beBeevalidation Full time €45,000 - €55,000
">Job Overview

We are seeking a highly skilled professional to fill the position of Validation Engineer. The successful candidate will play a critical role in supporting our validation activities for new tools and product introductions.

">Main Responsibilities
  • ">
  • Develop and execute process validation protocols and reports for new product introductions and revalidations.">
  • Implement solutions to sustain and improve our Quality Management System (QMS).">
  • Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.">
  • Participate in site change control, ensuring effective implementation of changes to validated processes.">
  • Generate risk assessments for cleaning, validation, and process.">
  • Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.">
  • Support GMP and regulatory audits.">
  • Analyze data and make informed decisions based on conclusions reached from analysis.
">Requirements
  • ">
  • A third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.">
  • Experience in statistical analysis (Minitab) / SPC / validations.">
  • Excellent interpersonal, communication, influencing, and facilitation skills.">
  • A minimum of two years experience as a Validation Engineer in an injection moulding or medical manufacturing environment.">
  • Minimum of five years experience working with Medical Devices.
">Desirable Skills
  • ">
  • Polymer expertise.">
  • Injection moulding knowledge.">
  • Lean six methods.">
  • Minitab.
">

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