Validation Engineer

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