Senior Validation Engineer
ICON View all jobs
- Dublin
- Permanent
- Full-time
- Designing, developing, and executing validation plans, protocols, and reports for systems, and processes in accordance with regulatory requirements.
- Working closely with engineering, IT, and quality assurance teams to identify validation needs and establish best practices in validation methodologies.
- Conducting risk assessments and impact analyses to evaluate the potential effects of changes to systems and processes.
- Maintaining accurate documentation of validation activities to support audits and inspections, ensuring compliance with GxP and other relevant regulations.
- Assisting ICON’s QA department with sponsor and regulatory requests.
- Providing mentorship and training to junior validation engineers, promoting a culture of continuous improvement and quality assurance.
- Bachelor’s degree in Engineering, Life Sciences, or a related field; a Master’s degree is a plus.
- Extensive experience in validation engineering within the healthcare, pharmaceutical, or clinical research industries.
- Strong knowledge of validation principles, methodologies, and regulatory requirements (e.g., GxP, FDA, EMA).
- Excellent problem-solving skills, with a detail-oriented approach to project management and execution.
- Strong communication skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.