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Details

Principal Quality Sterilisation Engineer (Microbiologist)


Reference:ABPV-755643 Location: Galway
Wexford
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

Principal Quality Sterilisation Engineer (Microbiologist)
Our client, a medical device multinational is currently recruiting for a Principal Quality Sterilisation Engineer (Microbiologist) to join their team on a permanent basis. The Principal Quality Sterilisation Engineer will be responsible for ensuring compliance to all relevant regulations for sterilisation and microbiology which includes the maintaining all quality systems and related documentation.

Responsibilities
• Co-ordination and control of sterilisation, biocompatibility (finished product and raw materials) and environmental monitoring (including all cleanrooms)
• Responsible for the training of the quality inspectors in relation to sterile release and for overseeing this approval.
• Ensure continued compliance with all Regulatory Standards such as ISO 11135, ISO 10993, ISO 14644, ISO 14698, ISO 11607, ISO 13485, FDA QSR &ISO 14000
• Ensuring continued compliance with Device Master Record
• Monitor all aspects of product and paperwork preparation for sterilisation, approval and environmental monitoring in the manufacturing process
• Ensure quality product is shipped to customer and provide, trend analysis of data, potential improvements for review based on the trends, areas for improvement to senior management and review and propose changes to sampling plans based on trend analysis and changes to the system.
• Ensure continuous compliance with related sterilisation validation standards & related biocompatibility and environmental standards
• Conduct training in sterilisation and microbiological and related procedures
• Drive the site validation for sterilisation, including all liaisons with the contract steriliser
• Interact and present sterilisation and microbiological documentation during audits
• Carry out a documented monthly evaluation of cleanrooms
• Support any meetings related to sterilisation and /or environmental monitoring to ensure that internal and customer concerns are handled and dealt with in an appropriate manner

Requirements
• Engineering or science Degree
• Qualification in microbiology is preferable
• A Six Sigma qualification will be a distinct advantage
• 1-3 years’ experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment
• Ability to communicate and work with people across the company
• Excellent communication skills
• Ability to co-ordinate, plan and organise in a timely manner
• Knowledge of engineering theories and methods, demonstrating an aptitude for analysis and problem solving.
• Rigorous attention to detail
• Ability to work independently and without direct supervision while maintaining adherence to timelines is fundamental to the role




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

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