Scientist, TS/MS - Device Assembly
Eli Lilly and Company
9 days ago
On-site
Concord, NC
Operations
Responsibilities:
- Support the Device Assembly Process Team as TS/MS representative.
- Serve as floor-level support and technical interface for device components, equipment, and operations for the TSMS team.
- Provide technical support to non-routine investigations (e.g., deviation, complaint), including quality and stability consultation.
- Represent the Concord TSMS team for internal and external communications.
- Lead risk management activities for product/process.
- Prepare and review technical documents (e.g., Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFEMAs).
- Develop, monitor, and react to statistically based real-time metrics to assess process variability and capability.
- Identify opportunities and lead technical projects to improve process control and/or productivity.
- Interface with upstream suppliers and global device/drug product networks.
- Drive stability strategy for Concord products.
- Provide audit support as needed.
Basic Requirements:
- Bachelor’s or equivalent (Science or Engineering related degree preferred).
- 2+ years’ experience in a manufacturing organization.
Additional Preferences/Skills:
- Pharmaceutical and/or medical device manufacturing experience.
- Root cause investigation experience.
- 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, teamwork, self-management, and organizational skills.
Additional Information:
- Monday through Friday; flexibility for production schedules/shutdowns; occasional extended/off-hour work.
- Based in Concord, NC; travel to Indianapolis and other global sites as required.
Benefits (listed):
- Company bonus; 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; certain time off/leave; well-being benefits (EAP, fitness, employee clubs/activities).
Application instructions:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
- Support the Device Assembly Process Team as TS/MS representative.
- Serve as floor-level support and technical interface for device components, equipment, and operations for the TSMS team.
- Provide technical support to non-routine investigations (e.g., deviation, complaint), including quality and stability consultation.
- Represent the Concord TSMS team for internal and external communications.
- Lead risk management activities for product/process.
- Prepare and review technical documents (e.g., Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFEMAs).
- Develop, monitor, and react to statistically based real-time metrics to assess process variability and capability.
- Identify opportunities and lead technical projects to improve process control and/or productivity.
- Interface with upstream suppliers and global device/drug product networks.
- Drive stability strategy for Concord products.
- Provide audit support as needed.
Basic Requirements:
- Bachelor’s or equivalent (Science or Engineering related degree preferred).
- 2+ years’ experience in a manufacturing organization.
Additional Preferences/Skills:
- Pharmaceutical and/or medical device manufacturing experience.
- Root cause investigation experience.
- 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, teamwork, self-management, and organizational skills.
Additional Information:
- Monday through Friday; flexibility for production schedules/shutdowns; occasional extended/off-hour work.
- Based in Concord, NC; travel to Indianapolis and other global sites as required.
Benefits (listed):
- Company bonus; 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; certain time off/leave; well-being benefits (EAP, fitness, employee clubs/activities).
Application instructions:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.