Our client, a rapidly expanding medical device manufacturing facility, requires a Validation Engineer. This is an opportunity to build your career with a global leader in its field.
Role
* Write and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
* Developing and implementing solutions to sustain and improve the Quality Management System (QMS).
* Maintain and support compliance to ISO 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.
* Directly supports 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/validation.
* Excellent interpersonal, communication, influencing, and facilitation skills.
* Experience as a Validation Engineer within an injection moulding or medical manufacturing environment preferred.