Senior Validation Specialist

6 days ago

Cork, Cork, Ireland beBeeValidation Full time €55,000 - €80,000

Job Overview

This is a Validation Manager position, responsible for overseeing the planning, coordination, and execution of validation activities within an organization. This includes ensuring compliance with regulatory standards, internal quality policies, and project requirements.

The role involves developing and implementing validation procedures, generating comprehensive reports, and supporting tender submissions by providing detailed validation documentation.

The Validation Manager will play a key role in offering technical validation support across projects, managing follow-ups to ensure timely closure of validation activities, and driving process improvements to enhance operational efficiency and compliance.

  • Develop, manage, and execute validation plans, protocols (IQ, OQ, PQ), and reports in compliance with regulatory and industry standards.
  • Lead validation efforts for HVAC equipment, facilities, lab equipment, and utilities systems.
  • Collaborate with cross-functional teams to define and execute validation requirements.
  • Maintain up-to-date knowledge of applicable regulations and ensure validation activities align with them.
  • Identify and resolve validation-related issues, providing risk assessments and remediation plans as needed.
  • Oversee the development and training of the validation team, ensuring high standards of competency and compliance.
  • Conduct annual reviews for the team.
  • Provide technical validation support for tender processes, including preparing and reviewing validation documentation as part of bid submissions.
  • Conduct validation follow-ups to ensure all identified actions and non-conformances are closed in a timely and compliant manner.
  • Create and refine validation procedures to align with regulatory and internal standards, ensuring repeatability and efficiency.
  • Manage validation project timelines, budgets, and resources effectively.
  • Drive continuous improvement initiatives within validation processes to enhance efficiency and compliance.

Key Requirements:

  • Relevant Engineering Qualification (i.e., Level 7 or Level 8 Mechanical).
  • Minimum of 5 years working within a Lead role within a regulated environment.
  • Experience in a GMP manufacturing environment.
  • Proficient in Microsoft Office (Excel, Word, PowerPoint).
  • Excellent communication skills, a confident and effective decision maker, with a proven ability to influence others.
  • Team player, with a flexible approach but also able to work under own initiative.
  • Strong verbal and interpersonal skills.
  • Competent level of technical writing and understanding of technical documentation.
  • Full clean driving licence.
  • Must be eligible to work in Ireland.

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