Sterilisation Manager
Our client, a global healthcare organisation are currently recruiting for a Sterilisation Manager for their medical device manufacturing and R&D site. As Sterilisation Manager you will be responsible for leading sterilisation activities in compliance with applicable quality systems, regulatory requirements, and internal policies. You will provide technical leadership and subject matter expertise across sterilisation validation, qualification and ongoing compliance.
Responsibilities
1. Lead a team responsible for sterilisation qualification for new products and changes to existing products
2. Manage radiation sterilisation validation, including dose setting and routine dose audits
3. Oversee ethylene oxide (EO) sterilisation validation, including new product qualification, annual revalidation, EO residual studies and D-value studies
4. Act as Sterilisation Subject Matter Expert, supporting Product Development, Manufacturing and Operations teams
5. Support supplier quality audits of external sterilisation vendors and third-party manufacturers
6. Lead investigations into dose audit failures
7. Lead investigations into EO biological indicator sterility positives
8. Ensure all activities are executed in line with regulatory and quality system requirements
Requirements
9. Bachelor's degree in a relevant scientific or engineering discipline
10. Minimum 9+ years' relevant experience, or an equivalent combination of education and experience
11. Advanced degree desirable
12. Strong technical knowledge of radiation and/or ethylene oxide sterilisation (other modalities advantageous)
13. Recognised Subject Matter Expert within sterilisation or microbiology
14. Proven experience leading technical teams in a regulated, quality-driven environment
15. Strong understanding of sterilisation validation, revalidation and troubleshooting
16. Ability to analyse complex technical issues and exercise sound judgement within established quality and regulatory frameworks
17. Experience working cross-functionally with R&D, Quality, Manufacturing and Supplier Quality teams
For more info get in touch with Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie