Principal Scientist - Visual Inspection

Company Overview:  

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 39,000 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. #WeAreLilly 

Organization Overview: 

The IPM Visual Inspection Steward is a technical position that develops and implements a technical agenda.  Primary objectives include reliable and compliant manufacturing of the parenteral products and improvement of the process control strategy focusing on the visual inspection process. 

Responsibilities:

The TS/MS Visual Inspection Steward role will report directly to the IPM Syringe Plant TS/MS Senior Director and will be responsible for driving the tech agenda and mentoring the technical staff.

• Own a technical agenda for syringe visual inspection platform, including Manual, Semi-Automatic, and Automatic inspection, including continuous improvement, compliance initiatives, process control, yield, and/or productivity.
• Serve as a technical mentor for Scientists, leaders, and other disciplines. Provide technical guidance to the TS/MS group.
• Provide technical support to non-routine (e.g., deviation, process removal) investigations, including consultation on quality issues, resort recommendations, and process changes. 
• Prepare, Review and Approve, as required, relevant technical documents, such as: Change Controls, , Deviations, Procedures, etc.
• Support identification and development of new inspection technologies and/or techniques. Subsequent implementation for the improvement of existing commercial manufacturing processes. 
• Understand and influence the manufacturing control strategy for the various operational areas.
• Drive control, capability, productivity, and continuous improvement for the process.
• Network and collaborate with global and other parenteral sites to understand best practices and share knowledge
• Support site inspection readiness and execution. This role may have direct interaction with Regulatory Agencies during site inspections.

Basic Requirements: 

• Bachelor’s Degree in scientific disciplines of Material Science, Chemistry, Biology, Pharmacy, Engineering, or equivalent.
• 3+ years of pharmaceutical manufacturing experience in TS/MS or associated disciplines such as Manufacturing, Quality Control, Quality Assurance, or Engineering.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

• Strong technical aptitude and ability to train and mentor others
• Proven Teamwork and interpersonal skills
• Problem solving and independent decision-making skills
• Oral and written communication skills that demonstrate an ability to effectively (e.g., clearly, succinctly) communicate with all levels of the organization.
• Ability to influence diverse groups
• Previous experience with deviation and change management systems
• Previous experience with regulatory agencies during site inspections
• Previous experience with visual inspection or defect classification – components incoming inspection and/or drug product inspection