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View Cache (Job ID 13875007)
Employer ICDS Recruitment
Job Title Validation Engineer

Validation Engineer - South Dublin.

In this role you will be accountable 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:
o Process Validation
o Facility Validation
o Software Validation
o 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, 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 Sought:
• Primary degree qualification in a science, engineering or business discipline.
• Minimum 2 years' experience in healthcare, medical device, 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.

• 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.

This job originally appeared on
Location Dublin South
Date Added 5 days ago
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