Validation Engineer

July 30, 2024

RBK

Longford

FULL TIME & OTHER

Job Summary

Our client, a privately owned Irish company based in Longford, is seeking to recruit an ambitious Validation Engineer. This is a hands-on role within a dynamic manufacturing environment. The Validation Engineer is responsible for supporting all validation activities associated with the successful qualification of new tools / product introduction, they will report to the Validation Engineer Manager and will support the organization to achieve the new product introduction objectives.

Key Responsibilities

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

Qualifications & Key Attributes

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