Role Summary
The Packaging Engineer for TS/MS in Concord, NC supports the implementation of technical objectives through execution activities and collaboration with packaging operations and engineering teams. Initially focuses on automated device assembly and packaging lines, serving as a technical resource. During commercial production, analyzes equipment/process data, monitors production metrics, authors and executes protocols, and supports process improvement and root cause investigations. Regular interface with packaging operations and engineering teams for day-to-day operations.
Responsibilities
- Support DAP Process Team as TS/MS representative.
- Provide technical support to non-routine investigations (e.g., deviation, complaint), including consultation on quality and stability issues.
- Prepare and review technical documents as needed (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 consultation on quality and product impact.
- Serve as floor-level support and technical interface for device components, equipment, and operations for the TS/MS team.
Qualifications
- Bachelors or equivalent (Science or Engineering related degree preferred).
Additional Preferences
- Pharmaceutical and/or medical device manufacturing experience
- Root cause investigation experience
- Ability to work independently or as part of a team to resolve issues
- Strong attention to detail
- Proficiency with Microsoft Office, Veeva Vault, TrackWise, electronic batch records, 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 with flexibility for production schedules, shutdowns, and occasional extended or off-hour work.
- Position based in Concord, NC with ability to travel to Indianapolis and other Lilly sites as required.