Biotech Cleaning Validation Specialist – Limerick

Eli Lilly and Company; Limerick; On-site; EUR 42,000 - 62,000; Full time

Job summary

Eli Lilly and Company in Limerick, Ireland, is seeking a Process Cleaning Representative to support the cleaning program for process equipment and ancillary components in the Biotechnology Manufacturing Facilities. You will develop cleaning strategies, author the Cleaning Validation Master Plan, generate validation protocols, and execute alongside operations, quality, and maintenance teams.

The ideal candidate holds a BSc (Hons) in Engineering or Science with 2 years' related experience, fluent

Qualifications

• BSc (Hons) in Engineering or Science with 2 years of related experience.
• Proficient in English.
• Technical knowledge of cleaning equipment (CIP skids, etc.) and cleaning regimes.
• Knowledge of qualification/validation requirements and good documentation practices.
• Understanding of biotech manufacturing processes and production scheduling.

Responsibilities

• Develop cleaning strategy in collaboration with Engineering and Quality counterparts for Lilly Limerick Monoclonal Facility.
• Author and own the Cleaning Validation Master Plan for the facility.
• Generate cleaning validation protocols and summary reports.
• Execute cleaning validation protocols, including visual inspection and sampling and coordination with other support groups.
• Author cleaning procedures and associated work instructions for all equipment.
• Develop cleaning batch records or appropriate documents to enable execution of cleaning activities on the production floor.
• Complete review of executed cleaning batch records/documentation.
• Trouble-shoot issues and optimize cleaning cycles and/or cleaning equipment.
• Provide technical support on cleaning deviations/events and assist in root cause analysis.
• Complete changes associated with cleaning equipment, cleaning cycles and cleaning program.
• Complete Periodic Review Reports for key components to ensure cleaning equipment remains in a qualified state.

Skills

Cleaning equipment

Validation & docs

Biotech manufacturing

Communication skills

Independent & teamwork

Prioritization

Education

BSc (Hons) in Engineering or Science

Job description

Eli Lilly and Company in Limerick, Ireland, is seeking a Process Cleaning Representative to support the cleaning program for process equipment and ancillary components in the Biotechnology Manufacturing Facilities. You will develop cleaning strategies, author the Cleaning Validation Master Plan, generate validation protocols, and execute alongside operations, quality, and maintenance teams.

The ideal candidate holds a BSc (Hons) in Engineering or Science with 2 years' related experience, fluent