Job Title: Validation Engineer
We are seeking a skilled and experienced validation engineer to join our client's team at their manufacturing site in Ireland. This is an exciting opportunity to work with a friendly and experienced team that has undergone major investment and expansion.
The ideal candidate will have prior experience in medical device and/or injection moulding, as well as excellent interpersonal, communication, influencing, and facilitation skills.
Key Responsibilities:
* Develop process validation protocols and reports for new product introductions and revalidations due to process/material improvements.
* Implement solutions to sustain and improve the quality management system (QMS).
* Maintain compliance to ISO standards.
* Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
* Generate risk assessments, covering cleaning, validation, and process.
* Review and execute factory acceptance testing and site acceptance testing protocols.
* Support good manufacturing practice (GMP) and regulatory audits.
* Prepare and deliver training modules as required.
* Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
* Support continuous improvement through lean six sigma methodologies.
* Execute change controls.
* Perform root cause analysis of system failures/substandard performance, using standard tools and methods, to resolve machine and system issues.
Requirements:
* Third-level qualification in engineering, polymer science, or equivalent manufacturing experience.
* Experience in statistical analysis (Minitab)/SPC/validation.
* Excellent interpersonal, communication, influencing, and facilitation skills.