Senior Validation Engineer – an excellent opportunity to join a leading medical device organisation based in Galway working on Sterilization Validation Protocols.
- Creation and approval of Sterilization Validation Protocols and Report.
- Review and approval of test results and associated test method validations.
- Collaboratively works with external contract sterilization test facility.
- Assess/Coordinate cycle consolidation opportunities.
- Support Operations and Design Service Project Teams.
- Management of process deviations, NCRs and CAPAs related to Sterilization Processes.
- Support of operations and design service project teams.
- Knowledgeable of the associated Quality System requirements.
- Responsible for maintenance of site Sterilization and Controlled Environment procedures.
- Conduct supplier auditing as required.
- Ownership of site product bioburden program.
- Management of the site environmental monitoring program.
- Gives guidance on cleanroom control.
- Assess changes to products and processes for impact on sterilization.
- BSc. in Science/Engineering.
- 5 years experience in the medical device or pharmaceutical.
- Knowledge of medical device products and regulations.
- Experience in industrial ethylene oxide sterilization.
- Microbiological experience in environmental monitoring, and laboratory procedures preferred.
- Auditing experience.
- Familiarity with regulations such as FDA, USP, AAMI, ANSI, ASTM, and ISO.
- Familiarity with the operation and maintenance of environmentally controlled manufacturing and testing facilities.
- Knowledge and experience of Ethylene Oxide Sterilisation validation and routine control.
- Knowledge of Microbiological and Environmental monitoring programs.
- Ability to effectively communicate both internally and externally.
- Ability to read and interpret documents.
- Must be authorised to work in Ireland.
Please contact Emer Moore to discuss in confidence