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 3073779 / firstname.lastname@example.org
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