Medical Device – Longford/Roscommon Ireland
CPL Recruitment are once again assisting our valued client to source a
Validation Engineer
to join their team.
This is an exciting opportunity to join a manufacturing site that has undergone major investment and expansion since 2022.
You will be working with a very friendly and experienced team that have a wealth of experience in the leadership team.
Prior Medical Device And/or Injection Moulding Experience Essential.
Get in touch for further information : Deirdre Murphy on / or (email protected)
Role
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.
Requirements
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
Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment essential.
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