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 partnerships with device assembly operations and engineering teams. Initially, this role supplements automated device assembly lines and serves as a technical resource for internal parties. As commercial production begins, objectives include analyzing equipment/process data, monitoring production metrics, authoring and executing protocols, and serving as a technical asset for process improvement and root cause investigations. The role interfaces regularly with device assembly operations and engineering teams to support day-to-day operations.

Responsibilities

• Support the Device Assembly Process Team as TS/MS representative.
• Provide technical support to non-routine investigations, including consultation on quality and stability issues.
• Prepare and review relevant 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 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

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

Skills

• Technical documentation and protocol execution
• Data analysis and interpretation of equipment/process data
• Root cause analysis and problem-solving
• Cross-functional collaboration with operations and engineering
• Attention to detail and process improvement
• Familiarity with manufacturing systems and quality systems

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, etc. Occasional extended hours or off-hour work may be required.
• Position will be based at the Concord, NC site with ability to travel to Indianapolis and other Lilly sites as required.