In this role you will be responsible for supporting all validation activities associated with the successful qualification of new tools / product introduction. You will support the organisation to achieve new product introduction objectives.
Key Responsibilities
* Write and execute process validation protocols and reports for new product introductions and re‑validations due to process / material improvements utilising scientific / technical knowledge.
* Developing and implementing solutions to sustain and improve the QMS.
* Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
* Participate in the 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 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 why’s etc.;
* Implement subsequent corrective action through the change management system.
* Participate / lead cross‑functional teams including liaising with vendors on projects.
Interested applicants should have
* 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.
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