Job Title: Senior Sterilisation Engineer
A leading global medical device company is currently seeking a highly skilled and experienced Senior Sterilisation Engineer to join their Research and Development team on a contract basis. This exciting role will focus on the development, validation, and transfer of sterilisation processes for a new Class III combination product.
The ideal candidate will work closely with internal teams and global sterilisation vendors to lead feasibility trials, protocol development, and regulatory submissions.
* Experience in development, validation & commercialisation of various sterilisation modalities such as Steam, EtO, Gamma, E-beam, and X-ray (Steam and EtO preferred).
* Experience in development & validation of sterilisation methods for liquids, pre-filled syringes, polymers, combination medical devices (drug delivery), and pharmaceuticals.
* Experience in setting up acceptance criteria for sterilisation and microbiology requirements of combination products.
* Experience in microbiology, bioburden, BI, and BNF testing of medical devices.
* Experience in new product development in the medical device industry.
* Experience in setting up sterilisation processes in manufacturing environments for commercial use.
* Experience in troubleshooting sterilisation cycle development & validation.
* Experience in supporting regulatory submissions for PMA devices.
Benefits:
* Competitive hourly rate: €50-60 per hour.
* Flexible working arrangements, with 1-3 days onsite per week and remote work options.
* Opportunity to work on challenging projects with a leading global medical device company.
About the Role:
* Conduct research and feasibility trials for sterilisation of new products.
* Engage with global sterilisation vendors to plan and manage process transfers.
* Write protocols, oversee vendor testing, and analyse data.
* Lead design reviews and recommend optimal sterilisation procedures.
* Ensure compliance with GMP practices and regulatory standards.
* Support regulatory documentation and submission processes.
This role is based in Limerick and requires 1-3 days onsite per week. If you have any expenses related to this role, please let us know so we can factor them into the rate.
If you are interested in this opportunity, please send your latest CV for consideration.