Scientist, TS/MS - Device Assembly

About the role

Lilly is seeking a Scientist within the Concord TS/MS Device Assembly process team to support the implementation of technical objectives through execution activities and partnerships with the device assembly operations and engineering teams. This role will initially assist in the setup of automated device assembly lines and provide technical support for non-routine investigations. Upon the commencement of commercial production, the role will focus on analyzing equipment/process data, monitoring production metrics, authoring and executing protocols, and serving as a technical asset for process improvement and root cause investigations.

Responsibilities

• Support the Device Assembly Process Team as TS/MS representative.
• Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues.
• Represent Concord TSMS team for internal and external communications on a regular basis.
• Lead risk management activities as it pertains to product/process.
• Prepare and Review, as required, relevant technical documents, such as: Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFEMAs, etc.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
• Identify opportunities and lead technical projects to improve process control and/or productivity.
• Drive stability strategy for Concord products.
• Provide Audit support as needed.
• Identify opportunities and participate in projects to improve process control and/or productivity.

Requirements

• Bachelor's or equivalent (Science or Engineering related degree preferred)
• 2+ years experience in a manufacturing organization

Additional Preferences

• Pharmaceutical and/or medical device manufacturing experience
• Root cause investigation experience
• Proven ability to work independently or as part of a team to resolve an issue
• Strong attention to detail
• Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP
• Knowledge and understanding of manufacturing processes
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills

Basic Requirements

• Bachelor's or equivalent (Science or Engineering related degree preferred)
• 2+ years experience in a manufacturing organization

Additional Information

• Position is Monday through Friday.
• Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.).
• Occasional extended hours and/or off-hour work may be required.
• Based out of Concord, NC site with ability to travel to Indianapolis and other global Lilly sites as required.