- 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 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.
- 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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Validation Engineer - Longford, Ireland - RBK
Description
Our client, a leading supplier for consumer goods, healthcare and industrial companies around the world, is seeking to recruit a Validation Engineer to support their expanding operations. The successful candidate will be responsible for supporting all validation activities associated with the successful qualification of new tools / product introduction. Reporting to the Quality Manager, they will support the organisation to achieve the new product introduction objectives.
Job Summary:
The role:
Qualifications & Key Attributes