Sr. Principal Engineer – TSMS Visual Inspection

Position Title

Sr. Principal Engineer – TSMS Visual Inspection

R4

TSMS

Associate Director – TSMS

Kenosha Site

The Visual Inspection Engineer – Technical Services / Manufacturing Science (TS/MS) role provides technical guidance for visual inspection operations and projects involving existing and new inspection processes.

The role is responsible for teaching, mentoring, and coaching personnel in all aspects relating to visual inspection processes within the Lilly Kenosha County site. The scope of the role includes visual inspection operations for commercially manufactured products at the Kenosha site.

The Visual Inspection Engineer is responsible for the training and qualification program associated with visual inspection, classification of defects, and ensuring overall scientific understanding of the program. This role will also participate in troubleshooting and driving continuous improvement as it relates to the visual inspection program.

The role will regularly interact with peers within the parenteral network and in Global TS/MS to share learnings and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.

• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Provide technical oversight regarding defect classification, visual inspection technique, and visual inspection qualification program to support production operations.
• Perform root cause analysis and apply scientific principles and understanding related to defect creation, prevention, and detection.
• Author, review, approve and provide technical support for the preparation of technical documents, including personnel qualification strategies, control strategies, investigations, change controls, expert opinions, procedures, processing records, validation protocols and summary reports, defect classifications, technical studies, regulatory submissions, etc.
• Provide technical support for non-routine investigations (e.g., deviations, complaints), including consultation on quality.
• Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations.
• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
• Serve as technical interface external to the Kenosha site.
• Provide audit support, as needed.
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

• Bachelors Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or other related scientific discipline
• Minimum 10 years of visual inspection of parenteral drug products
• Experience in TS/MS, MSAT, Quality, Engineering, or Operations
• Experience with data trending and analysis
• Previous experience with deviation and change management systems

• Ability to analyze complex data and solve problems
• Demonstrated successful leadership of cross-functional teams
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all…