Principal Scientist - Visual Inspection
Eli Lilly and Company
2 months ago
On-site
Indianapolis, IN
Operations
Organization Overview:
The IPM Visual Inspection Steward is a technical position that develops and implements a technical agenda, with objectives including reliable and compliant manufacturing of parenteral products and improvement of the process control strategy focusing on the visual inspection process.
Responsibilities:
- Own a technical agenda for syringe visual inspection (Manual, Semi-Automatic, Automatic), including continuous improvement, compliance initiatives, process control, yield, and/or productivity.
- Serve as a technical mentor for Scientists, leaders, and other disciplines; provide technical guidance to the TS/MS group.
- Support non-routine investigations (e.g., deviation, process removal), including consultation on quality issues, resort recommendations, and process changes.
- Prepare, review, and approve relevant technical documents (e.g., Change Controls, Deviations, Procedures).
- Support identification and development of new inspection technologies/techniques and implement improvements in existing commercial manufacturing.
- Understand and influence manufacturing control strategy across operational areas.
- Drive control, capability, productivity, and continuous improvement for the process.
- Network and collaborate with global and other parenteral sites to share best practices.
- Support site inspection readiness and execution; may interact with Regulatory Agencies during inspections.
Basic Requirements:
- Bachelor’s degree in Material Science, Chemistry, Biology, Pharmacy, Engineering, or equivalent.
- 3+ years pharmaceutical manufacturing experience in TS/MS or related disciplines (Manufacturing, Quality Control, Quality Assurance, Engineering).
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Skills/Preferences:
- Technical aptitude; ability to train and mentor.
- Teamwork/interpersonal skills; problem-solving and independent decision-making.
- Strong oral and written communication.
- Ability to influence diverse groups.
- Experience with deviation and change management systems.
- Experience with regulatory agencies during site inspections.
- Experience with visual inspection/defect classification (incoming components and/or drug product).
The IPM Visual Inspection Steward is a technical position that develops and implements a technical agenda, with objectives including reliable and compliant manufacturing of parenteral products and improvement of the process control strategy focusing on the visual inspection process.
Responsibilities:
- Own a technical agenda for syringe visual inspection (Manual, Semi-Automatic, Automatic), including continuous improvement, compliance initiatives, process control, yield, and/or productivity.
- Serve as a technical mentor for Scientists, leaders, and other disciplines; provide technical guidance to the TS/MS group.
- Support non-routine investigations (e.g., deviation, process removal), including consultation on quality issues, resort recommendations, and process changes.
- Prepare, review, and approve relevant technical documents (e.g., Change Controls, Deviations, Procedures).
- Support identification and development of new inspection technologies/techniques and implement improvements in existing commercial manufacturing.
- Understand and influence manufacturing control strategy across operational areas.
- Drive control, capability, productivity, and continuous improvement for the process.
- Network and collaborate with global and other parenteral sites to share best practices.
- Support site inspection readiness and execution; may interact with Regulatory Agencies during inspections.
Basic Requirements:
- Bachelor’s degree in Material Science, Chemistry, Biology, Pharmacy, Engineering, or equivalent.
- 3+ years pharmaceutical manufacturing experience in TS/MS or related disciplines (Manufacturing, Quality Control, Quality Assurance, Engineering).
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Skills/Preferences:
- Technical aptitude; ability to train and mentor.
- Teamwork/interpersonal skills; problem-solving and independent decision-making.
- Strong oral and written communication.
- Ability to influence diverse groups.
- Experience with deviation and change management systems.
- Experience with regulatory agencies during site inspections.
- Experience with visual inspection/defect classification (incoming components and/or drug product).