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Details

Senior Sterilisation Engineer


Reference:AGGW-546616 Location: Galway
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Microbiologist

Senior Sterilisation Engineer
Our Galway based client are currently recruiting for a Senior Sterilisation Engineer to join their team on a permanent basis. The Senior Sterilisation Engineer will work with the Product Development Teams and external customers to plan and execute Sterilisation Validation Activities, support key sterilisation programs such as sterile load process review and revalidation activities and will be responsible for monitoring and implementing changes to respective programs as improvements or updates are identified.

Responsibilities
• Create and approve Sterilisation Validation Protocols and Reports
• Review and Approve test results and associated test method validations
• Work 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 Sterilisation Processes
• Support Design Service Project Teams with ancillary Sterilisation activities such as test unit preparation and dunnage management
• Have knowledge of the associated Quality System requirements and interpretation of same ISO/FDA/AAMI related to sterilization
• Responsible for maintenance of site Sterilisation procedures
• Conduct supplier auditing as required
• May perform other duties as assigned

Requirements
• Level 8 Degree in Science/Engineering
• 5 years of demonstrated experience in the medical device or pharmaceutical industry with experience specific to ethylene oxide sterilisation cycle development and maintenance
• Knowledge of medical device products and regulations
• Experience in industrial ethylene oxide sterilisation; including microbial inactivation kinetics
• Microbiological experience in environmental monitoring, and laboratory procedures preferred
• Auditing experience


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252