ABOUT ABBOTT

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritional products. In Ireland, Abbott employs around 6,000 people across ten sites. We have manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, Kilkenny and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

EXPERIENCE:

• Relevant third level Degree in Science or equivalent.
• Minimum 3 years’ experience in Science or equivalent.
• Experience with ISO cleanrooms, bioburden testing and endotoxin testing is preferred.

MAIN PURPOSE OF ROLE

• Individual contributor with comprehensive knowledge in Microbiology and cleanroom environments.
• Ability to execute complex or specialized projects.

MAIN RESPONSIBILITIES

• Manage and maintain the site Environmental Monitoring program, ensuring the site complies with regulatory requirements, and ensure product to be manufactured with minimal levels of Bioburden & Endotoxin.
• Manage & co-ordinate Environmental monitoring activities, including microbiological service suppliers.
• Ensure cleanrooms are validated and controlled and comply with internal requirements and applicable regulations and standards.
• Analyze product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly.
• Lead and Support validation activities within the Microbiology area.
• Provide Facility and Operations Departments with Microbiological Support and support for issues in the areas of environmental monitoring and microbiological methods.
• Assure that all regulatory requirements are met and maintained to include FDA, GMP, and ISO requirements.
• Be a Microbiology / Cleanroom Subject Matter Expert during internal and external audits and support any Microbiology related observations and CAPA ‘s / QR’s.