Job Description
Our client a large Global Medical Device Manufacturing company are currently looking to recruit an experienced Sterilisation Engineer.
The Sterilisation Engineer will have an understanding and experience in compiling all the regulations governing sterilisation. You will ensures your direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
Responsibilities:
Responsible for Sterilisation regulatory and compliance activities at other Irish sites
Filing Sterilisation submissions to regulatory bodies
Key Sterilisation person at sites during external audits
Interactions with Regulatory bodies,
Management of Sterilisation activities to support product recertification projects at each site
Provide direction on interpretation of standards
Key role in the development and validation of new Sterilisation cycles.
Key role in qualification of new Sterilisation vendors and facilities
Regular communication with North America Corporate group
Significant contributor to Development of Corporate procedures
To provide assistance and support to the Sterilisation, RA and qualities groups as required.
Compliance to internal procedures and GMP practices
Experience interacting with contract sterilisation suppliers
Experience assessing routine sterilisation process outputs against established specifications
Requirements:
Min HETAC level 8 Degree in Science/ Engineering or any other relevant discipline
Good knowledge of MDD and FDA requirements
Good knowledge of EO E-Beam and Gamma Sterilisation
Knowledge of Sterilisation and Quality System Standards
Min. 2-5 years? experience in a similar role.
For further information on this Sterilisation Engineer position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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