Software Quality engineer
Software Validation Engineer (Contract) | Galway | 12 Months
A leading medical device manufacturer is seeking an experienced Software Validation Engineer to support manufacturing and quality systems within a highly regulated environment. This is an excellent opportunity to join a major organisation and play a key role in ensuring critical equipment and software remain compliant, validated, and audit-ready.
Location: Galway
Contract Length: 12 Months
Hours: 40 Hours per Week
Start Date: ASAP
Working Pattern: Hybrid (4 days onsite initially, moving to 3 days onsite per week thereafter)
Key Responsibilities
- Lead and support software validation and equipment qualification activities throughout the full validation lifecycle.
- Develop, review, and approve validation documentation including URS, risk assessments, IQ/OQ/PQ protocols, test scripts, and reports.
- Ensure all qualification and validation activities meet site procedures, regulatory requirements, and quality standards.
- Provide subject matter expertise in Computer System Validation (CSV), Data Integrity, 21 CFR Part 11, and Electronic Records/Electronic Signatures.
- Support change controls, deviations, CAPAs, and system modifications while maintaining compliance.
- Work closely with manufacturing, engineering, quality, and IT teams to ensure validated system performance and ongoing compliance.
Requirements
- Degree in Software Engineering, Computer Science, Electronics, Engineering, or a related technical discipline.
- Experience working within a regulated industry such as Medical Devices, Pharmaceuticals, Combination Products, or similar.
- Strong knowledge of Computer System Validation (CSV), Equipment Qualification, Validation Methodologies, Risk Management, and Software Development Lifecycles.
- Experience authoring and reviewing validation lifecycle documentation.
- Understanding of Data Integrity and 21 CFR Part 11 requirements.
- Exposure to programming and automation tools such as Python, C#, C++, Java, VB.Net, SQL, Power BI, Power Automate, or AI-based applications would be advantageous.
What's on Offer?
- Long-term 12 month contract with potential for extension.
- Opportunity to work on complex validation projects within a global medical device environment.
- Hybrid working arrangement with flexibility following the initial onboarding period.
- Exposure to cutting-edge manufacturing, quality, and digital systems.
If you're interested in learning more, please apply with an updated CV.
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