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Validation engineer

Lough
Barrington James
Validation engineer
Posted: 19 February
Offer description

Validation Engineer – Longford, IrelandWe're currently looking for a skilled Validation Engineer to join a well-established medical manufacturing company based in Longford, Ireland. This role will be instrumental in supporting the qualification and validation of new tools and product introductions. If you have a passion for process validation, a solid foundation in ISO 13485, and experience in an injection moulding or medical manufacturing environment, this could be the perfect opportunity for youKey Responsibilities:Write and execute process validation protocols and reports for new product introductions and revalidations.Develop and implement solutions to sustain and improve the Quality Management System (QMS).Maintain compliance with ISO 13485 and ISO 14001 systems standards.Participate in site change control to identify and implement changes to validated processes.Perform risk assessments covering cleaning, validation, and process.Review and execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) protocols.Support GMP and regulatory audits.Deliver training modules as required.Use Lean Six Sigma methodologies for continuous improvement.Lead root cause analysis of system failures and implement corrective actions.Qualifications & Key Attributes:Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.At least 2 years of experience as a Validation Engineer in injection moulding or a medical manufacturing environment.Experience in statistical analysis (Minitab), SPC, and process validations.Strong interpersonal, communication, and facilitation skills.Experience with risk management, FMEA, and corrective actions.Fluency in English (both written and verbal) is essential.If this sounds like a great fit for your background, feel free to send me a message or apply below. We look forward to hearing from you

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