Validation Engineer

2 weeks ago

Longford, Ireland Cpl Full time

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CPL Recruitment is assisting a valued client in sourcing a
Validation Engineer
to join their team.
This is an exciting opportunity to work at a manufacturing site that has undergone significant investment and expansion.
You will be part of a friendly and experienced team with extensive leadership expertise.
Prior experience in medical devices and/or injection moulding is essential.
Get in touch for further information: Deirdre Murphy on
01 /
or
other contact details
.
Role Responsibilities
Write and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements, utilizing scientific/technical knowledge.
Develop and implement solutions to sustain and improve the QMS.
Maintain and support compliance with ISO standards.
Participate in site change control, ensuring changes to validated processes are effectively managed.
Generate risk assessments covering cleaning, validation, and process.
Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
Support GMP and regulatory audits.
Prepare and deliver training modules as required.
Perform data analysis and provide informed decisions and recommendations based on data.
Support continuous improvement initiatives using Lean Six Sigma methodologies.
Execute and develop change controls.
Perform root cause analysis of system failures using standard tools like FMEA, Fishbone diagrams, and 5 Whys.
Implement corrective actions through the change management system.
Participate in or lead cross-functional teams, including liaising with vendors.
Requirements
Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
Experience in statistical analysis (Minitab), SPC, and validations.
Excellent interpersonal, communication, influencing, and facilitation skills.
Experience as a Validation Engineer within an injection moulding or medical manufacturing environment is essential.
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