Validation Engineer
In this role, you will support all validation activities associated with the successful qualification of new tools and product introductions.
Main Responsibilities:
* Write and execute process validation protocols and reports for new product introductions and re-validations due to process/material improvements using scientific/technical knowledge.
* Developing and implementing solutions to sustain and improve the Quality Management System (QMS).
* Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
* Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
* Generation of risk assessments, covering cleaning, validation, and process.
* Review and execution of 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.
* Execution/development of 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/validations.
* Excellent interpersonal, communication, influencing, and facilitation skills.
* A minimum of 2 years' experience as a Validation Engineer within an injection moulding or medical manufacturing environment.
Skills:
* Validation engineer medical device injection moulding