Senior Sterilisation Engineer
Job ID: JOB-11749
Senior Sterilisation Engineer
A leading medical device manufacturer in Limerick is recruiting for a Senior Sterilisation Specialist to join their team on a permanent basis. The primary purpose of this position is for the Management of the sterilisation programme.
- Responsibility for the Management of the sterilisation programme including validation and re-validation of contract sterilisation.
- Responsible for Sterilization related queries associated with internal and external audits
- Performing product assessment against microbiology requirements in relevant standards.
- Become part of the Global Sterilisation team and lead projects.
- Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820.
- Responsibility for completing appropriate sterilization requirements as part registration of the products in various markets.
- Preparation, execution and analysis of related Quality documentation.
- Ensure that the Code of Conduct is considered in all business matters carried out on the company’s behalf.
Qualifications / Requirements:
- Third level Qualification in Microbiology with at least 5 years experience in a similar role (relevant experience in same with equivalent third level Science Qualification will be considered).
- ETO Sterilisation experience is essential for this role.
- A strong knowledge of biocompatibility is desirable.
- Thorough knowledge and experience of a regulated industry, including GMP, GDP, GLP.
- Knowledge of medical device quality standards/practises or similar regulated industry such as ISO10993, EN550, EN ISO 11135-1 and 11737-1.
- Knowledge of regulatory requirements.
- Good knowledge of CAPA, NCR and deviation process.
- Good communication both written and verbal and good inter-personal skills.
- Proven problem-solving skills.
- Good computer skills including knowledge of Microsoft® Office.
- Proven organisational skills.
- High self-motivation and proven team member skills.
- Willingness and availability to travel on company business.
For further information on this Senior Sterilisation Engineer role in Limerick please contact Clara Burke on 086 8168273 firstname.lastname@example.org
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