Software Validation Engineer

EPM Scientific; Galway; Hybrid; EUR 52,000 - 75,000; Full time

Job summary

A leading medical device manufacturer in Galway is seeking a Software Validation Engineer on a 12‑month contract. The role focuses on validating software and equipment within a highly regulated environment to ensure compliance, traceability, and audit readiness.

You will develop and review validation documents (URS, IQ/OQ/PQ, risk assessments), support change controls, and collaborate with manufacturing, engineering, quality and IT.

Qualifications

• Degree in Software Engineering, Computer Science, Electronics, Engineering, or a related technical discipline.
• Experience in regulated industry (Medical Devices, Pharmaceuticals, etc.).
• Strong knowledge of CSV, Equipment Qualification, Validation Methodologies, Risk Management, and SDLC.
• Experience authoring and reviewing validation documentation.
• Understanding of Data Integrity and 21 CFR Part 11.
• Exposure to programming/automation tools such as Python, C#, C++, Java, VB.Net, SQL, Power BI, Power Automate, or AI-based apps would be advantageous.

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 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.

Skills

Regulatory compliance

Technical writing

Cross-functional collaboration

CSV familiarity

Education

Bachelor's degree in Software Engineering/Computer Science/Engineering

Tools

Python

C#

C++

Java

VB.Net

SQL

Power BI

Power Automate

Job description

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.