SterilISAtion Validation Engineer
CPL
Offaly
Our client, a medical devices company in the Midlands are currently recruiting for a Sterilisation Validation Engineer. ROLE ACCOUNTABILITIES. The Sterilisation Validation Engineer will be responsible for completing validation activities associated with EO Sterilisation compliance to ISO11135:2014 and sterilisation and microbiological activities related to product changes. Key duties will include but will not be limited to: Complete sterilisation validations/annual revalidations in accordance with ISO11135, including protocol and report writing, validation planning, execution and result evaluation. Support sterilisation/microbiology projects including cycle development, optimisation and new/revised equipment validation. Support Engineering to ensure new products and product changes are adequately evaluated/tested with respect to sterilisation, bioburden, residual and biocompatibility requirements ensuring compliance with related regulatory standards Evaluate product changes to determine the level of testing required. Liaise with engineers to determine test requirements and obtain test samples. Liaise with test laboratories to solicit testing and receipt of test reports. Ensure all required testing is completed in a timely manner to meet project timelines. Adhere strictly to company policies and procedures as notified. Assist in the maintenance of a safe company culture by working within the company’s environmental, health and safety guidelines at all times and reporting any equipment or process problems in line with plant escalation procedures. Identify continuous improvements opportunities where possible and take part in improvement projects as assigned. Adhere to GMP based Quality Systems requirements for medical devices and medicinal product (e.g. MDD, EU GMP Guidelines Vol IV Part 1 for medicinal product, ISO 13485. Carry out additional duties that may be assigned. QUALIFICATIONS. A degree in Science, Engineering or Quality related discipline. A minimum of 3 years working within a regulated industry, preferably Medical Devices. Experience with sterilisation, quality engineering and/or microbiological activities would be advantageous. Experience of compliance with ISO11135, ISO10993-1, ISO10993-7, ISO11737, ISO14644 and ISO14698 would be advantageous. Strong communication and technical writing skills. High attention to detail in all aspects of the role. Ability to work with cross-functional teams, including engineering, production, quality and materials. If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. This job originally appeared on RecruitIreland.com.
2255 days ago