Manufacturing Associate - Advanced Manufacturing
Eli Lilly and Company
6 days ago
On-site
Lebanon, IN
Operations
Position Overview
The Manufacturing Associate performs routine GMP manufacturing activities at the Lebanon Advanced Therapies, LP2 site across Cell Culture, Downstream Purification, and Fill & Finish. Supports equipment qualification, develops site procedures, and sets up production areas during startup; once operational, executes production activities on their shift.
Responsibilities
- Work cross-functionally (TSMS and Engineering) to develop procedures, MES records, and operational controls.
- Produce advanced therapies in a cleanroom safely and with quality.
- Coordinate production with Quality Control/Quality Assurance/Plant Maintenance for on-time release.
- Support equipment commissioning/qualification testing and process validation.
- Safely work with BSL-2 materials per biologics safety program.
- Execute and document production using digital manufacturing batch records and SOPs.
- Monitor/operate manufacturing equipment to meet performance and safety standards.
- Partner with maintenance, equipment vendors, and QA to ensure equipment is in validated working order.
- Provide clear verbal/written reports; maintain complete electronic records/logbooks (cGLP/cGMP).
- Follow all cGLP/cGMPs, policies, and regulatory requirements; comply with cleanroom gowning.
Minimum Requirements
- Bachelor’s degree in a STEM field.
- Or high school diploma + 5 years of relevant pharmaceutical manufacturing operations experience.
- Authorized to work in the U.S. (no visa sponsorship).
Additional Preferences
- Experience with automatic/manual/semi-automated equipment.
- Technical problem-solving, strong oral/written communication, organization, attention to detail.
- Ability to learn digital systems; understanding/adherence to GMP.
Other Information
- Start-up: primarily day shift; later 4 x 10-hour rotating shifts. Some overtime required.
Benefits (if eligible)
- 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits; company bonus (performance-based).
The Manufacturing Associate performs routine GMP manufacturing activities at the Lebanon Advanced Therapies, LP2 site across Cell Culture, Downstream Purification, and Fill & Finish. Supports equipment qualification, develops site procedures, and sets up production areas during startup; once operational, executes production activities on their shift.
Responsibilities
- Work cross-functionally (TSMS and Engineering) to develop procedures, MES records, and operational controls.
- Produce advanced therapies in a cleanroom safely and with quality.
- Coordinate production with Quality Control/Quality Assurance/Plant Maintenance for on-time release.
- Support equipment commissioning/qualification testing and process validation.
- Safely work with BSL-2 materials per biologics safety program.
- Execute and document production using digital manufacturing batch records and SOPs.
- Monitor/operate manufacturing equipment to meet performance and safety standards.
- Partner with maintenance, equipment vendors, and QA to ensure equipment is in validated working order.
- Provide clear verbal/written reports; maintain complete electronic records/logbooks (cGLP/cGMP).
- Follow all cGLP/cGMPs, policies, and regulatory requirements; comply with cleanroom gowning.
Minimum Requirements
- Bachelor’s degree in a STEM field.
- Or high school diploma + 5 years of relevant pharmaceutical manufacturing operations experience.
- Authorized to work in the U.S. (no visa sponsorship).
Additional Preferences
- Experience with automatic/manual/semi-automated equipment.
- Technical problem-solving, strong oral/written communication, organization, attention to detail.
- Ability to learn digital systems; understanding/adherence to GMP.
Other Information
- Start-up: primarily day shift; later 4 x 10-hour rotating shifts. Some overtime required.
Benefits (if eligible)
- 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits; company bonus (performance-based).