ICDS Recruitment
Job title:
Validation Engineer – County Longford
Company
ICDS Recruitment
Job description
Validation Engineer – County Longford.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.
Expected salary
Location
Co Longford
Job date
Thu, 08 May 2025 22:59:05 GMT
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