Validation Engineer

My client, a Galway based Medical Device organisation, are looking to hire a new Validation Engineer .

This role will suit someone with a Level 8 or higher degree in an engineering or science discipline.

This is a permanent role based on-site in Galway City.

Responsibilities

• Oversee and manage testing activities with relevant functional teams, ensuring clear communication and thorough evaluation of test outcomes.
• Assist in updating and enhancing the validation program to comply with current cGMPs and industry practices.
• Collaborate with teams on the specification, installation, validation, troubleshooting, and maintenance of equipment and systems.
• Develop and revise validation plans, reports, and procedural documentation.
• Work with Manufacturing and Automation Engineering to design, document, execute, and refine process validations, ensuring adherence to ISO13485 and PMDA guidelines where applicable.
• Perform manual testing for software and system validation, documenting and analyzing results with precision.
• Partner with software developers and experts to create, document, and improve verification tests, ensuring compliance with FDA (21CFR11), ISO, PMDA, and GAMP 5 standards.
• Provide early-stage guidance on computer system validation needs during project planning phases.

Requirements

• Level 8 in engineering or a science-related field.
• At least 2 years of relevant experience in the medical device or pharmaceutical industries.
• Background in validations or experience with quality systems, process controls, and continuous improvement methods.
• Familiarity with test method validation processes.
• Practical knowledge of validation principles, industry standards, risk assessments, CAPA processes, and change control systems.
• Proficiency in Computer Systems Validation, Automation, or Software Quality Assurance practices.

For more information, please contact [email protected]

*please note you must be eligible to work in Ireland full time (Stamp 4/EU)