Our client a medical device manufacturing company requires an experienced Sterilization Engineer for their site in Galway. The successful candidate will be providing support to the Design organization to facilitate efficient sterilization validations within the design area, to optimize existing processes, and to ensure that project goals are met. Also the candidate will monitor interfaces with Quality and Research and Development organizations to integrate new products or processes into the existing or new Sterilization cycles.
- Responsible for compliance with applicable Corporate Policies and procedures.
- Generating Sterilization qualification / validation protocols and routing through approval process.
- Coordinating and supporting execution of protocols.
- Deliver samples to the laboratory for analysis, coordinate timing and testing activities, tabulate and compile results.
- Support investigation related to failures, perform root cause analysis, support corrective actions, and drive closure of investigations related to qualification / validation activities.
- Approve and coordinate activities with external test laboratories, including: obtaining price quotes, supporting the generation of test protocols, coordination shipment / receiving of materials.
- Lead or support (as applicable) investigations, root cause analysis and corrective actions for deviations and out-of-specification results.
- Generate final reports and support final approval.
- Interacts cross functionally and with internal and external customers. Serves as a consultant for engineering or scientific interpretations and advice on significant matters. Acts as a spokesperson to customers on Sterilization.
Education, Experience and Skills:
- Bachelor's degree (Microbiology, Engineering) plus 6+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience.
- Experience in Sterilization Operations and validations with Ethylene oxide sterilization.
- Product Development experience ideal
- Strong Communication skills
- CAPA/Investigation Skills
For further information on this Sterilization Engineer role in Galway please contact Cliona O'Malley on 091730022 / firstname.lastname@example.org
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