Scientist - Process Cleaning

4 weeks ago

Limerick, Ireland Eli Lilly and Company Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.

Main Purpose and Objectives of Position:

The Process Cleaning Scientist will be responsible for supporting the cleaning program for process equipment and ancillary components in the Biotechnology Manufacturing Facilities at Lilly, Limerick.

NOTE: This is a technical role and the successful candidate will need to meet the required qualifications and experience outlined below.

Key Responsibilities:
  1. Develop cleaning strategy in collaboration with Engineering and Quality counterparts for Lilly Limerick Monoclonal Facility.
  2. Author and own the Cleaning Validation Master Plan for the facility.
  3. Generate cleaning validation protocols and summary reports.
  4. Execute cleaning validation protocols, including visual inspection and sampling and coordination with other support groups (e.g. operations, maintenance, lab, etc.).
  5. Author cleaning procedures and associated work instructions for all equipment.
  6. Develop cleaning batch records or appropriate documents to enable execution of cleaning activities on the production floor.
  7. Complete review of executed cleaning batch records/documentation.
  8. Trouble-shoot issues with and optimize cleaning cycles and/or cleaning equipment.
  9. Provide technical support on cleaning deviations/events and assist in root cause analysis.
  10. Complete changes associated with cleaning equipment, cleaning cycles and cleaning program.
  11. Complete Periodic Review Reports for key components to ensure cleaning equipment remains in a qualified state.
Additional Skills/Preferences:
  1. Technical knowledge of cleaning equipment (CIP skids, Parts washers, etc.) and cleaning regimes (chemical, re-circulated washing, etc.).
  2. Knowledge of qualification/validation requirements and good documentation practices.
  3. Knowledge of Biotech manufacturing processes and understanding of production schedules.
  4. Strong written and verbal communication skills.
  5. Ability to work on own initiative and as part of a process team consisting of a diverse group of management, production/science and engineering professionals.
  6. Ability to respond quickly and proactively to changing priorities within a limited timeline.
Educational Requirements:

BSc (Hons) in either Engineering or Science with 2 years similar experience supporting the cleaning program for process equipment and ancillary components in a pharmaceutical / biopharmaceutical manufacturing site.

Language Requirements:

Proficient in English.

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