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Manufacturing Engineer Sterilisation
Manufacturing Engineer - Sterilisation
Our client, a medical device company in Galway is currently looking to recruit a Manufacturing Engineer with ETO Sterilization experience for their site.
Provide daily support of products, processes, material and equipment in order to achieve production goals.
Analyses process, product, material or equipment specifications and performance requirements within the site sterilization facility
Under broad supervision/guidance complies and analyses operational, test and experimental data to establish performance standards for newly implemented or modified products/processes.
Summarizes, analyses and draws conclusions from test results leading to effective technical resolution.
Troubleshoots new products /process working closely with product development.
Continually seeks to drive/improvements in process design. Layout and operational performance of both the sterilization and packaging operations.
Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
Actively promotes and participates in cross functional teamwork environment.
Evaluates in conjunction with EHS new equipment / processes / chemicals for environmental impact/ effect to eliminate or lessen such impacts/ effects.
Gives technical guidance to Associate Engineers and Technicians.
Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the Manufacturing Engineering Department and Site objectives?
Demonstrate a primary commitment to patient safety and product quality.
Understands and comply with all the regulations governing the quality systems.
Provides both quality and technical input to the design reviews, project development/ design change/recertification plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
Experienced in validation techniques, risk management, statistical techniques and compliance to regulatory requirements. Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects.
Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
Excellent analytical and problem solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
Updates Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group.
Degree (Level 8) qualified. Ideally in Materials/ Engineering discipline with a minimum of 5 years work experience.
Demonstrated working knowledge of the setup, maintenance and troubleshooting of Ethylene Oxide sterilisation systems and cycle validations is a must.
Excellent technical capabilities, communication skills, teamwork abilities and initiative.
Proven ability to work well both as an apart of a team and to work on their own with minimum supervision.
Industry experience in combined Ethylene Oxide sterilisation and medical device packaging technologies a distinct advantage.
For further information on this Sterilisation Engineer role in Galway please contact Deirdre on 086 (phone number removed) / email@example.com
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