Validation Engineer
This is a unique opportunity to build your career with a global leader in medical device manufacturing.
Job Description
* 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 (e.g., FMEA, Fishbone diagrams, 5 whys, etc.).
* Implement subsequent corrective action through the change management system.
* Participate/lead cross-functional teams, including liaising with vendors on projects.
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.
* Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment preferred.