Job Overview:
We are seeking a highly skilled Validation Engineer to support all validation activities associated with the successful qualification of new tools/product introduction.
* Responsibilities include writing and executing process validation protocols and reports for new product introductions and re-validations due to process/material improvements utilizing scientific/technical knowledge.
* The ideal candidate will be responsible for developing and implementing solutions to sustain and improve the Quality Management System (QMS).
* Maintenance and support of compliance to ISO 13485 and ISO 14001 systems standards is crucial.
* The engineer will participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
* Risk assessments will be generated, covering cleaning, validation, and process.
* Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols will also be performed.
* Directly supporting Good Manufacturing Practice (GMP) and regulatory audits is essential.
* The engineer will prepare and deliver training modules as required.
* Data analysis will be performed, and informed decisions/recommendations will be made around conclusions reached from data analysis.
* Support for continuous improvement through Lean Six Sigma methodologies will be provided.
* Execution/development of change controls will be carried out.
* Root cause analysis of system failures/substandard performance will be performed using standard tools and methods to resolve machine and system issues (e.g. FMEA, Fishbone diagrams, 5 whys etc.).
Required Skills and Qualifications:
* A third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience is necessary.
* Experience in statistical analysis (Minitab)/SPC/validation is essential.
* Excellent interpersonal, communication, influencing, and facilitation skills are required.
* A minimum of 2 years experience as a Validation Engineer within an injection moulding or medical manufacturing environment is preferred.
Work Environment:
* Longford, Ireland.
Language:
* English (required).
Job Requirements:
1. Job Description.
2. Required Skills and Qualifications.
3. Work Environment.