Sr. Validation Scientist/Engineer - Cleaning - API Manufacturing

Role Summary

Sr. Validation Scientist/Engineer - Cleaning - API Manufacturing. Responsible for cleaning verification/validation activities supporting API manufacturing processes, developing and executing cleaning validation documentation and strategies, and ensuring compliance with global standards. This includes collaboration across Engineering, Manufacturing, Quality Assurance, Quality Control, Validation, Development, and Regulatory departments, with a training assignment at a separate Lilly facility in Limerick, Ireland.

Responsibilities

• Responsible for cleaning verification/validation activities supporting API manufacturing processes at the site.
• Work closely with technical leadership to actively manage cleaning development and cleaning verification/validation activities according to schedule.
• Author and maintain product-specific cleaning validation documents including: Cleaning Validation Master Plans (CVMP), Cleaning Flow Documents (CFD), and Cleaning Validation Protocols and Summary Reports.
• Oversee execution of cleaning validation protocols and ensure alignment with approved strategies. Provide support to the process teams for cleaning activities ensuring all aspects of the flow are coordinated appropriately. Attend and lead (if required) process team meetings.
• Coordinate investigations related to cleaning. Trend events across equipment trains and products and drive improvements.
• Improve efficiency in cleaning processes and identify projects for improvement (e.g. activities that can run in parallel and those that need to run in sequence).
• Collaborate globally across Lilly sites to promote shared learning and continuous improvement in cleaning validation practices.
• Apply science- and risk-based approaches to enhance the robustness, efficiency, and compliance of cleaning processes.
• Develop and deliver training and educational materials on cleaning validation and related topics across Lilly manufacturing and packaging operations.
• Ensure cleaning validation activities are aligned with governing standards set by regulatory agencies and internal Lilly quality standards.

Qualifications

• Bachelor‚Äôs degree in Pharmacy, Science, Engineering or related field; advanced degree preferred.
• Minimum 5 years of relevant experience in pharmaceutical manufacturing/packaging and cleaning validation.
• Candidate must be mobile to temporarily locate in Ireland.

Preferences

• Practical experience with cGMPs and cleaning validation practices across multiple processes.
• Experience directly supporting manufacturing operations is highly desirable.
• Ability to apply cleaning validation principles across drug substance and various other manufacturing technologies.
• Familiarity with regulatory guidance and standards governing cleaning validation.
• Strong self-management and organizational skills. Strong analytical and problem-solving skills.
• Proven ability to work independently and collaboratively within cross-functional teams.
• Demonstrated capability to critically evaluate technical issues, manage multiple priorities, and meet project deadlines.
• Oral and written communication skills that demonstrate an ability to effectively communicate with all levels of the organization.

Skills

• Cleaning validation, validation documentation, CVMP, CFD, QA/QC collaboration
• Technical leadership, project management, cross-functional teamwork
• Risk-based thinking, scientific troubleshooting, training development

Education

• Bachelor‚Äôs degree in Pharmacy, Science, Engineering or related field; advanced degree preferred.

Additional Requirements

• Language Requirements: Fluent in English
• This is a fully on-site position located in Lebanon, IN after the 6 month training period in Limerick, Ireland concludes