I am recruiting a Sterilization Engineer for a cutting-edge Medtech company in Co. Limerick. The ideal candidate will have experience in the development, validation & commercialization of various sterilization modalities such as steam, EtO, X-ray, Ebeam etc. Steam and EtO preferred.
Responsibilities:
- Development & validation of sterilization methods for liquids, pre-filled syringes, polymer, combination medical devices (drug delivery) & pharmaceuticals etc.
- Setting up acceptance criteria for sterilization and microbiology requirements of combination products.
- Experience in Microbiology, bioburden, BI, BNF testing of medical devices.
- New product development in medical device industry.
- Setting up sterilization process in manufacturing environments for commercial use.
- Troubleshooting in steri cycle development & validation.
- Supporting Regulatory submissions for PMA devices.
Requirements:
Expertise and knowledge of sterilization specific and industry standards such as listed below but not limited to:
- ISO 11135 – Ethylene Oxide (EO) Sterilization
- ISO 11137 (Parts 1–3) – Radiation Sterilization (Gamma or Electron Beam)
- ISO 11138-1- Sterilization of healthcare products – Biological indicators – Part 1: General requirements.
- ISO 17665-1 – Moist Heat Sterilization (Autoclaving)
- ISO 11737-1 and -2 – Bioburden Testing and Sterility Testing
- USP: <71>: Sterility Tests, <85>: Bacterial Endotoxins Test, <1207>: Package Integrity Evaluation (relevant for container-closure integrity)
- European Pharmacopoeia (Ph. Eur.): 2.6.1: Sterility, 5.1.2: Biological indicators and validation, 5.1.1: Methods of sterilization
- General: 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 210/211 (cGMP for drugs), ISO 13485 – Quality Management Systems for Medical Device
- ISO 13485 - Medical devices — Quality management systems — Requirements for regulatory purposes
- ISO 14971 - Application of risk management to medical devices
