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View Cache (Job ID 13851131)
Employer ICDS Recruitment
Job Title Validation Engineer. (Medical Device)

Validation Engineer. Dublin

Reporting to the Validation Supervisor,you will beaccountable for the following functional areas in the Quality department:

Process, Facility, Software and Equipment Validations.

Key Responsibilities

  • Key Team member for the following functions within the Quality Department :

    • Process Validation

    • Facility Validation

    • Software Validation

    • Equipment Validation

  • Support and contribute to a Quality culture based upon risk management, process mastery, data-driven analytics and goal-oriented performance accountability.

  • Support the maintenance of an effective Quality Management System that complies with international standards and relevant regulatory requirements e.g., EU IVDD, HPRA, FDA, Health Canada, etc.

  • Understand new regulations and guidelines, as they apply to the company, and implement systems and procedures to incorporate these new regulations.

  • Establish, track and respond to leading and lagging Quality Key Performance Indicators (KPIs) for functional areas under responsibility.

  • Process ownership of Validation Systems.

  • Ensure clear and unambiguous requirements for validation activities

  • Provide and support validation resources for cross-departmental projects; manage these resources within a defined project management framework.

  • Ensure that all validation protocols and reports meet the requirements of the Quality Management System

  • Prepare, maintain and review Quality System documents relating to validation, (IQ, OQ, PQ, URS etc)

  • Prepare and maintain Risk Assessments

  • Support product and facility inspections.

Qualifications / Experience

  • Primary degree qualification in a science, engineering or business discipline.

  • Minimum 2 year experience in in vitro diagnostics or related industry.

  • Validation protocols and reports.

  • Project management of cross-functional teams.

  • Building and leading effective teams, and highly motivated individuals.

Skills and Behaviours

  • Ability to articulate and gain consensus for the Quality perspective in business decisions; provide effective solutions for key business stakeholders.

  • Excellent verbal and written communication skills

  • Technical writing expertise in validation processes, protocols and reports.

  • In-depth knowledge of validation requirements.

  • Ability to successfully implement change.

  • Strong analytical/problem-solving skills.

  • Ability to collaborate with and influence groups in a positive, team‑based environment.

  • Work with a sense of urgency; be impartial and objective.

This job originally appeared on
Location Dublin South
Date Added 68 days ago
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