Ref No: AM17437
Co. Dublin, Ireland
Senior Scientist - Sterilisation Technology: Dublin.
In this role, as a leading member of Research and Development (R&D), the Senior Scientist- Sterilisation Technology will provide subject matter expertise and vision in the identification and development of sterilisation technologies for traditional and combination healthcare products. The successful candidate will have a background in engineering and microbiological principles as it relates to sterilisation, including experience assessing and deploying novel sterilisation methods and technologies or deploying traditional technologies in new ways. This role will lead the identification and selection of appropriate sterilisation technologies and support of sterilisation validation efforts for products to assure the sterilisation process is robust and compliant with regulations, standards and company policies and procedures.
Core Duties and Responsibilities:
• Serve as technical leader and subject matter expert for the development of sterilisation processes supporting early-stage product development and technology scouting projects.
• Promote innovation through research-based and data-driven identification of viable sterilisation technologies for next generation drug / therapy containment and delivery systems.
• Support market growth initiatives through creatively and thoughtfully challenging status-quo in sterilisation process deployment to provide unique and appropriately scaled solutions to routine & novel sterilisation challenges.
• Author research reports, design experiments, and execute feasibility studies to assess efficacy of sterilisation processes in a given application and/or impact of sterilisation on a medical device and/or drug product.
• Generate empirical evidence supporting sterilisation validation efforts in accordance with international standards (e.g., ISO 11137, ISO 11135, etc.), international regulations, and industry best practice.
• Lead and support cross-functional teams in test plan execution, data analysis, and conclusion generation within the product development process for sterilisation technology projects.
• Train and mentor teams, including junior personnel, while sharing experience and best practices related to sterilisation technologies, regulatory requirements, and corporate policy.
• Lead initiatives on behalf of the Global Sterilisation Council and foster an environment based upon a foundation of continuous process improvement and industry benchmarking.
Interested applicants should have:
• Bachelor’s degree in physical sciences, such as Microbiology, Biomedical Engineering or related engineering discipline
• At least 5 years' experience in healthcare product development and validation of sterilisation processes.
Ideally you might also have:
• Practical knowledge of sterilisation principles and prior education or experience with healthcare product design and/or manufacturing processes, microbiological test methods, validation. Experience with X-Ray, UV, NO2, or H202 sterilisation a plus.
• Previous leadership / mentorship experience a plus
• Must have effective problem-solving abilities and strong interpersonal and communication skills (both written and oral)
• Must be dependable, detail oriented, and able to multi-task
• A sense of urgency/initiative