Are you an early-career engineer looking to build hands-on experience in sterility assurance and validation within a regulated medical device environment? This is a fantastic opportunity to join a collaborative team where you'll gain exposure across manufacturing, design, and quality functions while developing your validation expertise.
What You'll Be Doing
As a Sterilisation Validation Engineer, you'll support critical sterility assurance and validation activities, including:
1. Supporting routine Sterility Assurance activities such as GMP compliance, cleanroom risk assessments, limits reviews, dose audits, cycle requalification, and supplier change control
2. Supporting sterility assurance for new products and product changes, partnering closely with manufacturing and design teams
3. Participating in root cause investigations and continuous improvement initiatives, driving corrective actions through to implementation
4. Supporting cross-functional teams with design and validation protocols to ensure compliance with regulatory standards
5. Collaborating with engineering and manufacturing to ensure quality and compliance standards are embedded
6. Developing and implementing inspection, testing, and evaluation methods for products and production equipment
7. Performing data analysis, calculations, data integrity checks, and maintaining compliant documentation
8. Ensuring all activities align with site safety procedures, GMP, and regulatory requirements
What We're Looking For
9. A University Degree in Engineering, Science, or a related discipline
10. 1–2 years' experience in a regulated manufacturing or medical device environment (validation, quality, or engineering exposure is ideal)
11. Knowledge of GMP and regulatory standards
12. Strong analytical, documentation, and problem-solving skills
13. Ability to work collaboratively within cross-functional teams
14. A proactive mindset with a strong focus on learning and development
Why Apply?
15. Hybrid working model in Galway
16. Excellent exposure to sterilisation validation and regulatory compliance
17. Supportive environment for early-career engineers
18. Opportunity to work on real projects from design through implementation
Interested in learning more please apply directly or email your CV to to learn more.
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