Our client, a medical device company in Galway is currently looking to recruit a Senior Microbiology & Sterilisation Engineer for their site.
Working with Operations, Product Development Teams and / or external customers to plan and execute Sterilization Validation Activities. Supports key sterilization programs such as sterile load process review and revalidation activities and other related activities such as product bioburden monitoring. Ownership of site product bioburden program. Responsible for the management of the site environmental monitoring program. Responsible to monitor and implement changes to respective programs as improvements or updates are identified.
Quality and Reliability Engineering Teams analyse the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labour, as well as failure analysis, root cause, corrective action and customer communication.
- Creation and approval of Sterilization Validation Protocols and Report.
- Review and Approval of test results and associated test method validations.
- Collaboratively works with external contract sterilization test facility.
- Assess/Coordinate cycle consolidation opportunities.
- Support Operations and Design Service Project Teams with respect to validation of product in approved cycles.
- Management of process deviations, NCRs and CAPAs related to Sterilization Processes.
- Support of Operations and Design Service Project Teams with ancillary Sterilization activities such as test unit preparation and dunnage management.
- Knowledgeable of the associated Quality System requirements and interpretation of same ISO/FDA/AAMI related to sterilization.
- Responsible for maintenance of site Sterilization and Controlled Environment procedures.
- Conduct supplier auditing as required.
- Ownership of site product bioburden program.
- Management of the site environmental monitoring program.
- Gives guidance on cleanroom control with respect to monitoring, routine operations, impact of non-conformances and assessment of change.
- Assess changes to products and processes for impact on sterilization and the controlled environments.
- May perform other duties as assigned.
- Level 8 Degree in Science/Engineering.
- 5 years of demonstrated experience in the medical device or pharmaceutical industry with experience specific to ethylene oxide sterilization cycle development and maintenance.
- Knowledge of medical device products and regulations.
- Experience in industrial ethylene oxide sterilization; including microbial inactivation kinetics.
- Microbiological experience in environmental monitoring, and laboratory procedures preferred.
- Auditing experience.
- Familiarity with regulations and standards published by FDA, USP, AAMI, ANSI, ASTM, and ISO.
- Demonstrated decision making skills and effective problem-solving abilities.
- Familiarity with the operation and maintenance of environmentally controlled manufacturing and testing facilities.
- Knowledge and experience of Ethylene Oxide Sterilisation validation and routine control required.
- Knowledge of Microbiological and Environmental monitoring programs preferred.
- Proficient in the following computer software applications: Microsoft Office.
- Exceptional interpersonal skills.
- Strong organizational skills.
- Strong communication skills (written and verbal).
- Ability to effectively communicate both internally and externally.
- Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals.
- Technical Writing skills.
For further information on this Senior Microbiology & Sterilisation Engineer role in Galway please contact Clara Burke on 086 8168273 / email@example.com
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