Sr. Validation Scientist/Engineer - Cleaning - API Manufacturing at Eli Lilly and Company

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.

Organization Overview:

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Main Purpose and Objectives: 

This position is responsible for supporting and maintaining the cleaning program for process equipment and ancillary components at the Lebanon manufacturing facility.  This position will interact with Engineering, Manufacturing, Quality Assurance, Quality Control, Validation, Development, and Regulatory departments.  Interaction may be required with other Lilly site/contract producers of Lilly products. 

This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.  The successful candidate should have a proven track record of driving technical and manufacturing agendas in small molecule.

Key Responsibilities:

• Understand the scientific principles for pharmaceutical manufacturing, including the interaction of the chemistry, equipment, and clean room operation.
• Understand the equipment cleaning requirements based on manufacturing process and chemistry.
• Development, implementation, and support of contamination control strategy programs, cleaning validation plans, and environmental monitoring programs.
• Author and support the execution of validation protocols and reports.
• Author cleaning procedures and associated work instructions.
• Support periodic requalification activities for production equipment and systems.
• Remain current on new industry and regulatory trends relating to cleaning equipment and cleaning regimes.
• Provide technical guidance to the Process Team for cleaning processes.
• Perform coupon cleanability and product recovery studies to support the cleaning programs.
• Provide technical support and advice on cleaning deviations/events and assist in root cause analysis and trouble-shooting efforts as required.
• Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements of the cleaning processes.
• Review cleaning batch records in a timely manner to support batch release.
• Participate or provide guidance for equipment cleaning programs during internal and external audits, including regulatory inspections, as needed.
• Prepare, review, approve, and provide technical support for the preparation of relevant technical documents as required, such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, process flow documents, etc.
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Ensure a safe working environment through compliance with safety rules and improve safety culture.

Minimum Requirements:

• BS degree in Chemistry, Biochemistry, Bio/Chemical Engineering or related engineering discipline.  Advanced degree (MS or PhD) preferred but not required.
• 3+ years of experience in a cGMP large-scale pharmaceutical manufacturing facility. 
• Technical knowledge of cleaning equipment and cleaning regimes.
• Knowledge of relevant FDA regulations relating to equipment cleaning in small molecule manufacturing.

Additional Preferences:

• Excellent communication skills, both oral and written.
• Ability to independently master assigned processes and to coordinate activities with internal and external partners.
• Experience in organic synthesis.
• Experience in API manufacturing.
• Ability to respond quickly and proactively to changing priorities within a limited timeline.

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