Senior Sterilization Engineer
Our client, an medical device company in Galway is currently looking to recruit a Senior Sterilization Engineer for their site.
Senior Sterilization Engineer works with Product Development Teams and / or external customers to plan and execute Sterilization Validation Activities. Supports key sterilization programs such as sterile load process review and revalidation activities. Responsible to monitor and implement changes to respective programs as improvements or updates are identified.
Key Job Responsibilities
- Creation and approval of Sterilization Validation Protocols and Reports
- 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 Design Service Project Teams with respect to validation of product in approved cycles.
- Management of process deviations, NCRs and CAPAs related to Sterilization Processes
- Support Design Service Project Teams with ancillary Sterilization activities such as test unit preparation and dunnage management
- Knowledgeable of the associated Quality System requirements and interpretation of same ISO/FDA/AAMI related to sterilization.
- Responsible for maintenance of site Sterilization procedures
- Conduct supplier auditing as required.
- May perform other duties as assigned
- Familiarity with regulations and standards published by FDA, USP, AAMI, ANSI, ASTM, and ISO.
- Demonstrated decision making skills and effective problem solving abilities.
- Familiarity with the operation and maintenance of environmentally controlled manufacturing and testing facilities.
- Knowledge of Microbiological and Environmental monitoring programs preferred.
- Proficient in the following computer software applications: Microsoft Office
- Exceptional interpersonal skills.
- Strong organizational skills.
- Strong communication skills (written and verbal).
- Ability to effectively communicate both internally and externally.
- Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals.
- Technical Writing skills
- Four-year Level of Degree in the microbiology, biology or biomedical science/engineering
- 3 years of demonstrated experience in the medical device or pharmaceutical industry with experience specific to ethylene oxide sterilization cycle development and maintenance.
- Knowledge of medical device products and regulations.
- Experience in industrial ethlene oxide sterilization; including microbial inactivation kinetics.
- Microbiological experience in environmental monitoring, and laboratory procedures preferred
- Auditing experience.
For further information on this Senior Sterilization Engineer role in Galway please contact Orla Crowley on 086 0449473/ email@example.com
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