Validation Engineer
Medical Device
Longford/Roscommon Ireland
CPL Recruitment are once again assisting our valued client 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 01 614 6178 / 087 180 4358 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.
#LI-DM1
