Validation Engineer
11 hours ago
Our client, a privately owned Irish company based in Longford, is seeking to recruit a Validation Engineer.
This person will be responsible for supporting all validation activities associated with the successful qualification of new tools/ product introduction.
He or She 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 whys 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.
Requirements Minimum of 5 years experience working with Medical Devices Strong expertise and knowledge of Injection Moulding Proven track record in validation within regulated environments Skills: "Polymer" "Engineering" "Injection moulding" "Lean six methods" "minitab"
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