Manufacturing Validation Specialist

4 days ago


Longford, Ireland Rbk Full time
Job Summary
Rbk, a leading Irish company based in Longford, is seeking an ambitious Quality Validation Engineer to join our team. This hands-on role within our dynamic manufacturing environment will support all validation activities associated with the successful qualification of new tools / product introduction.

The Validation Engineer will report to the Validation Engineer Manager and support the organization to achieve new product introduction objectives. Key responsibilities include:
  1. Write and execute process validation protocols and reports for new product introductions and revalidations due to process / material improvements utilizing scientific / technical knowledge.
  2. Developing and implementing solutions to sustain and improve the QMS.
  3. Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
  4. Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
  5. Generation of risk assessments, covering cleaning, validation, and process.
  6. Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
  7. Directly supports GMP and regulatory audits.
  8. Prepare and deliver training modules as required.
  9. Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis.
  10. Support continuous improvement through Lean Six Sigma methodologies.
  11. Execution / development of change controls.
  12. 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.
,

A minimum of 2 years' experience as a Validation Engineer within an Injection moulding or medical manufacturing environment is required. Third level qualification in Engineering, Polymer Science, or equivalent is also essential. Strong interpersonal, communication, influencing, and facilitation skills are necessary for success in this role.

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