Process Cleaning Scientist

4 weeks ago

Limerick, Ireland Cpl Healthcare Full time
Scientist - Process Cleaning

About the Role

Our biopharma client based in Limerick is dedicated to advancing healthcare by bringing life-changing medicines to patients worldwide. Their state-of-the-art Biotech Drug Substance Manufacturing Facility in Limerick is designed to be one of the most technically advanced manufacturing sites in the industry, utilising next-gen technologies and advanced data platforms to enhance safety, quality, and productivity.

This is a unique opportunity to contribute to the development and operation of this cutting-edge manufacturing facility from the ground up.

Main Purpose and Objectives of the Position

The Process Cleaning Scientist will support the cleaning program for process equipment and ancillary components in the biotechnology manufacturing facilities at our biopharma client in Limerick.

Note: This is a technical role, and the successful candidate must meet the qualifications and experience outlined below.

Key Responsibilities

  1. Author and own the Cleaning Validation Master Plan for the facility.
  2. Develop cleaning strategy in collaboration with Engineering and Quality counterparts for the Limerick Monoclonal Facility.
  3. Generate cleaning validation protocols and summary reports.
  4. Execute cleaning validation protocols, including visual inspection and sampling, and coordinate with other support groups (e.g., operations, maintenance, lab).
  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. Review executed cleaning batch records/documentation.
  8. Troubleshoot issues and optimise 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 the cleaning program.
  11. Complete Periodic Review Reports to ensure cleaning equipment remains in a qualified state.

Additional Skills/Preferences

  1. Technical knowledge of cleaning equipment (CIP skids, parts washers) and cleaning regimes (chemical, re-circulated washing).
  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 independently and as part of a process team, including management, production/science, and engineering professionals.
  6. Flexibility to respond quickly and proactively to changing priorities within a limited timeline.

Educational Requirements

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