Essential skills:
1. Experience in development, validation & commercialisation of various sterilisation modalities such as Steam, EtO, Gamma, E-beam, and X-ray (Steam and EtO preferred).
2. Experience in development & validation of sterilisation methods for liquids, pre-filled syringes, polymers, combination medical devices (drug delivery), and pharmaceuticals.
3. Experience in setting up acceptance criteria for sterilisation and microbiology requirements of combination products.
4. Experience in microbiology, bioburden, BI, and BNF testing of medical devices.
5. Experience in new product development in the medical device industry.
6. Experience in setting up sterilisation processes in manufacturing environments for commercial use.
7. Experience in troubleshooting sterilisation cycle development & validation.
8. Experience in supporting regulatory submissions for PMA devices.
9. Expertise and knowledge of sterilisation-specific and industry standards including:
10. Experience managing the full sterilisation cycle from feasibility through to validation.
11. Strong communication skills and ability to collaborate with global vendors and cross-functional teams.
12. Experience supporting regulatory submissions for FDA and CE marking.
Responsibilities:
13. Conduct research and feasibility trials for sterilisation of new products.
14. Engage with global sterilisation vendors to plan and manage process transfers.
15. Write protocols, oversee vendor testing, and analyse data.
16. Lead design reviews and recommend optimal sterilisation procedures.
17. Ensure compliance with GMP practices and regulatory standards.
18. Support regulatory documentation and submission processes.
The start date is for ASAP. The initial contract length is for 12 months, with options to extend after. The role is based in Limerick and will require 1-3 days onsite per week, the rest of the time you can work remotely. The rate is €50-60 per hour, depending on experience, if you have any expenses please let me know and I can factor that into the rate for you.