Advisor - Equipment Cleaning - TSMS - Lebanon API Manufacturing

Role Summary

The Cleaning Advisor supports site-wide strategy and cleaning validation activities for API manufacturing at Lilly Lebanon API. Responsible for managing the cleaning program for process equipment and ancillary components, the role collaborates with engineering, manufacturing, QA, QC, validation, development, and regulatory teams to ensure compliant cleaning strategies and validation documentation, guiding the startup of GMP manufacturing operations.

Responsibilities

• Maintain existing strategies and supporting documentation related to:
  • Cleaning equipment and cleaning cycles
  • Cleaning validation, verification, re-qualification, and re-validation
  • Cleaning limits
  • New product introduction and cleaning challenge determination
  • Cleaning procedures and associated work instructions
• Author new strategies and supporting documentation to meet changing business needs.
• Collaborate with technical leadership to manage cleaning development and cleaning verification/validation activities according to schedule.
• Oversee execution of cleaning validation protocols and coordinate with process teams to ensure alignment with strategies; attend or lead process team meetings as required.
• Provide technical support and advice on cleaning deviations/events; trend data across equipment trains and products to drive improvements.
• Provide technical review of changes to assess potential impact on the cleaning program and validation.
• Collaborate globally across Lilly sites to promote shared learning and continuous improvement in cleaning validation practices.
• Stay current on industry and regulatory trends related to cleaning equipment and cleaning regimes.
• Represent the cleaning program, validation status, and results in regulatory interactions and inspections.
• Apply science- and risk-based approaches to enhance robustness, efficiency, and compliance of cleaning processes.
• Develop and deliver training and educational materials on cleaning validation across LP1 manufacturing operations.
• Ensure cleaning validation activities align with governing standards from regulatory agencies and Lilly quality standards.

Qualifications

• Required: Bachelor’s degree in Pharmacy, Science, Engineering, or related field; advanced degree preferred.
• Required: Minimum 10 years of relevant experience in pharmaceutical manufacturing.
• Required: Minimum 5 years of experience directly supporting manufacturing operations for cleaning equipment and cleaning regimes, including ensuring compliance with FDA and EU regulations.

• Preferred: Ability to apply cleaning validation principles across drug substance and various manufacturing technologies.
• Preferred: Demonstrated technical leadership skills; strong familiarity with regulatory guidance and standards governing cleaning validation.
• Preferred: Strong self-management, organizational, analytical, and problem-solving skills; ability to work independently and within cross-functional teams; adaptability to changing priorities.
• Preferred: Effective oral and written communication across all levels of the organization.