Job Description
This position is responsible for providing support to the validation team in ensuring the quality and integrity of new tools and product introductions.
The Validation Engineer will be accountable for writing and executing process validation protocols and reports for new product introductions and revalidations due to process material improvements. They will also develop and implement solutions to sustain and improve the Quality Management System (QMS) while maintaining compliance to ISO 13485 and ISO 14001 standards.
The successful candidate will participate in site change control, effectively identifying and implementing changes to validated processes. They will also generate risk assessments covering cleaning validation and process, review and execute Factory Acceptance Testing and Site Acceptance Testing protocols, and directly support Good Manufacturing Practice (GMP) and regulatory audits.
Additionally, the Validation Engineer will prepare and deliver training modules as required, perform data analysis, and make informed decisions and recommendations based on conclusions reached from data analysis. They will also support continuous improvement through Lean Six Sigma methodologies, execute development of change controls, perform root cause analysis of system failures and substandard performance using standard tools and methods, and implement subsequent corrective action through the change management system.
Required Skills and Qualifications
* Third-level qualification in Engineering or Polymer Science or equivalent.
* Manufacturing experience.
* Experience in statistical analysis and Minitab SPC validations.
* Excellent interpersonal communication, influencing, and facilitation skills.
Benefits
This role offers a challenging and rewarding opportunity to work with Medical Devices and Injection Moulding, with a proven track record in validation within regulated environments.
About Us
We are seeking a highly skilled and experienced Validation Engineer to join our team and support us in achieving our New Product Introduction objectives.