Job Summary
A dynamic and ambitious Validation Engineer is sought by our client, a privately owned Irish company based in Longford.
This hands-on role will be part of a dynamic manufacturing environment, where the successful candidate will support all validation activities associated with new tool/product introductions.
Key Responsibilities:
* Develop process validation protocols and reports for new product introductions and revalidations, utilizing scientific and technical knowledge.
* Implement solutions to sustain and improve the Quality Management System (QMS).
* Maintain compliance to ISO 13485 and ISO 14001 systems standards.
* Participate in site change control to ensure effective implementation of validated processes.
* 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.
* Analyze data and make informed decisions/recommendations.
* Support continuous improvement through Lean Six Sigma methodologies.
* Execute/change controls.
* Perform root cause analysis using standard tools/methods to resolve machine/system issues.
* Implement corrective actions through the change management system.
* Lead/participate in cross-functional teams, liaising with vendors on projects.
Qualifications & Key Attributes:
* Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
* Experience in statistical analysis (Minitab)/SPC/validations.
* Excellent interpersonal, communication, influencing, and facilitation skills.
* A minimum of 2 years' experience as a Validation Engineer in an Injection moulding or medical manufacturing environment.
Description:
The Validation Engineer plays a crucial role in ensuring the quality and safety of products within a dynamic manufacturing environment.
The ideal candidate will possess a strong background in engineering, polymer science, or equivalent manufacturing experience.
Responsibilities include developing process validation protocols, maintaining compliance to ISO standards, and participating in site change control.
Strong analytical and problem-solving skills are essential for this role, along with excellent communication and interpersonal skills.
A minimum of 2 years' experience as a Validation Engineer in an Injection moulding or medical manufacturing environment is required.