Principal Scientist Visual Inspection Steward

Principal Scientist Visual Inspection Steward

Eli Lilly Benelux

Alzey, Germany

Responsibilities:

The TS/MS Visual Inspection (VI) Principal Scientist will assume responsibility across the manufacturing site in terms of ownership and harmonization of local control strategy that are implemented and executed at the site with regarding the Visual Inspection program.

As a Subject Matter Expert (SME), he is a key member in a cross-functional team who provides technical guidance for inspection operations and projects and is responsible for teaching, mentoring and coaching personnel in all aspects relating to visual inspection processes.

The VI Principal Scientist is responsible for the training and qualification program associated with visual inspection and classification of defects and ensuring overall scientific understanding of the program.

She/He also participates in troubleshooting and driving continuous improvement as it relates to the visual inspection program. The visual inspection Principal Scientist can also participate in investigations, regulatory inspections and collaborate in site inspection readiness programs.

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

Key Objectives/Deliverables:

• Serve as technical subject matter expert and program owner for all topics related to visual inspection supporting the site
• Is responsible with respect to implementation of regulatory guidance (e.g. USP ), technological advancements, and understanding of how changes could impact Eli Lilly
• Provide technical oversight regarding defect classification, visual inspection technique, and visual inspection qualification program to support production operations
• Provide technical support for non-routine investigations (e.g., deviations, complaints)
• Author, review, or approve technical documents, including personnel qualification strategies, control strategies, investigations, change controls, expert opinions, qualifications, procedures, defect classifications, personnel qualification strategies, control strategies, technical studies, etc.
• Develop, monitor, and appropriately react to established statistically based metrics to assess process variability and capability
• Own the development and implementation of process improvements to improve process control, yield, and/or efficiency
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits

Basic Qualifications:

• Minimum of bachelor's degree in science or engineering field
• Minimum 2+ years proven experience in visual inspection of pharmaceutical products
• Preferred 5+ years proven experience directly supporting pharmaceutical manufacturing or quality, with experience in visual inspection of pharmaceutical products

Skills/Preferences:

• Technical writing and communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential
• Ability to train/coach others and cross functional influence are critical in this role
• Ability to communicate to diverse groups on sophisticated regulatory, business, or technical issues within the site and function
• Experience in basic statistics and ANSI Standards
• Build relationships with internal and external customers and partners
• Proficiency in delivering highly sophisticated tasks and/or tasks that are highly cross-functional
• Strong analytical and quantitative problem-solving skills
• Demonstrated Project Management skills and ability to coordinate complex projects
• Strategic thinking and ability to balance short term needs with long term business evolution