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:
- Supporting routine Sterility Assurance activities such as GMP compliance, cleanroom risk assessments, limits reviews, dose audits, cycle requalification, and supplier change control
- Supporting sterility assurance for new products and product changes, partnering closely with manufacturing and design teams
- Participating in root cause investigations and continuous improvement initiatives, driving corrective actions through to implementation
- Supporting cross-functional teams with design and validation protocols to ensure compliance with regulatory standards
- Collaborating with engineering and manufacturing to ensure quality and compliance standards are embedded
- Developing and implementing inspection, testing, and evaluation methods for products and production equipment
- Performing data analysis, calculations, data integrity checks, and maintaining compliant documentation
- Ensuring all activities align with site safety procedures, GMP, and regulatory requirements
What We’re Looking For
- A University Degree in Engineering, Science, or a related discipline
- 1–2 years’ experience in a regulated manufacturing or medical device environment (validation, quality, or engineering exposure is ideal)
- Knowledge of GMP and regulatory standards
- Strong analytical, documentation, and problem-solving skills
- Ability to work collaboratively within cross-functional teams
- A proactive mindset with a strong focus on learning and development
Why Apply?
- Hybrid working model in Galway
- Excellent exposure to sterilisation validation and regulatory compliance
- Supportive environment for early-career engineers
- Opportunity to work on real projects from design through implementation
Interested in learning more please apply directly or email your CV to [email protected] to learn more.
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