Scientist, TS/MS - Device Assembly

Role Summary

The Scientist within the Concord TS/MS Device Assembly process team supports the implementation of technical objectives through execution activities and collaboration with device assembly operations and engineering teams. This role initially supplements automated device assembly lines and serves as a technical resource for internal parties. During commercial production, objectives include analyzing equipment and process data, monitoring production metrics, authoring and executing protocols, and contributing to process improvement and root cause investigations. Regular interface with operations and engineering teams is expected for day-to-day support.

Responsibilities

• Support the Device Assembly Process Team as TS/MS representative.
• Provide technical support to non-routine investigations (e.g., deviation, complaint), including quality and stability considerations.
• Prepare and review technical documents such as Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFEMAs, etc.
• Identify opportunities and participate in projects to improve process control and/or productivity.
• Provide technical support for non-routine investigations, including assessment of quality and product impact.
• Serve as floor-level support and technical interface for device components, equipment, and operations for the TS/MS team.

Qualifications

• Required: Bachelors or equivalent (Science or Engineering related degree preferred).
• Preferred: Pharmaceutical and/or medical device manufacturing experience; root cause investigation experience; proven ability to work independently or as part of a team; strong attention to detail; proficiency with Microsoft Office, Veeva Vault, TrackWise, electronic batch records, and SAP; knowledge of manufacturing processes; strong interpersonal and teamwork skills; strong self-management and organizational skills.

Education

• Bachelors or equivalent (Science or Engineering related degree preferred)

Additional Requirements

• Role is Monday through Friday. Must be flexible to support production schedules, shutdowns, and occasional extended or off-hour work.
• Position will be based in Concord, NC with ability to travel to Indianapolis and other Lilly sites as required.
• Travel expectations: ability to travel to Indianapolis and other global Lilly sites as required.