Validation Engineer
We have a current opportunity for a Validation Engineer on a contract basis. The position will be based in Ireland. For further information about this position please apply.
Key Responsibilities:
- Lead and support validation activities including development of Validation Master Plans and execution of IQ/OQ/PQ protocols.
- Collaborate with contract manufacturers to ensure product quality, timelines, and regulatory compliance.
- Develop and review technical documentation including protocols, reports, and design history files.
- Provide engineering support for injection molded components, including tooling, material selection, and process optimisation.
- Participate in risk assessments, root cause analysis, and CAPA investigations.
- Ensure compliance with relevant standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, MDR).
- Support continuous improvement initiatives across manufacturing and quality processes.
Requirements:
- Proven experience in medical device engineering, preferably in a regulated environment.
- Strong background in injection molding and contract manufacturing.
- Demonstrated expertise in protocol/report writing, validation master plans, and IQ/OQ/PQ processes.
- Familiarity with regulatory requirements and quality systems (ISO, FDA, MDR).
- Excellent communication and documentation skills.
- Ability to work cross-functionally in a fast-paced environment.
FAQs
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