Scientist/Engineer – Technical Operations - Lilly Medicine Foundry
Eli Lilly and Company
1 month ago
On-site
Lebanon, IN
Operations
Key Responsibilities
- Provide on-the-floor shift support for operations staff for technical, training, and process support; at times execute production activities.
- Evaluate processes/protocols and real-time deviations; assess and communicate findings to cross-functional process teams.
- Execute equipment commissioning and qualification testing using independent judgment under guidance of C&Q.
- Conduct and document production via digital manufacturing batch records and affiliated SOPs.
- Follow all applicable procedures, cGLP, cGMPs, and quality/regulatory requirements.
- Document and assess improvement opportunities from operators.
- Coordinate with area maintenance to schedule work orders for corrective maintenance.
- Lead Safety and Quality Investigations and author investigation reports.
- Collaborate cross-functionally to enable Foundry technology transfers.
- Serve as a key resource for operational improvement projects and initiatives.
- Plan and coordinate process campaign changeovers (cleandown, piping, maintenance, equipment setup); oversee execution to meet timelines.
- Work with PE, PTE, PRD, HSE, and Quality Assurance to ensure successful process transfer and execution.
- Apply Health/Safety/Process Safety standards; represent operations in Process Hazard Review (PHR) and other HSE venues.
- Promote continuous improvement of area changeover workflows.
Basic Requirements
- Bachelor’s or Associate’s degree in science/engineering/technical field, or HS Diploma/GED with 5+ years pharmaceutical manufacturing operations experience (Small Molecule, Biologics, or Mixed Modalities), including operations support, safety/quality incident investigations, authoring procedures/instructions, and process hazard reviews.
- Authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Preferences
- Pharmaceutical Product Research and Development experience.
- GMP experience supporting cleaning, changeover, and/or maintenance activities.
- Formal project management training; demonstrated leadership/influencing.
- Facility/area start-up experience.
- Solid understanding of FDA guidelines and cGMP requirements.
- Strong organizational skills; ability to troubleshoot/triage; understand technical nomenclature and math.
- Effective written, verbal, and electronic communication.
Other Information / Role Logistics
- Travel: ~5%.
- On-site, M–F schedule with flexibility to support 24/7 manufacturing operations nights and weekends as needed.
Benefits (as stated)
- Eligible for company bonus (company and individual performance).
- 401(k) eligibility; pension; vacation; medical/dental/vision/prescription; flexible benefits (e.g., healthcare/dependent day care FSAs); life insurance; time off/leave; well-being benefits (e.g., EAP, fitness, employee clubs).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Provide on-the-floor shift support for operations staff for technical, training, and process support; at times execute production activities.
- Evaluate processes/protocols and real-time deviations; assess and communicate findings to cross-functional process teams.
- Execute equipment commissioning and qualification testing using independent judgment under guidance of C&Q.
- Conduct and document production via digital manufacturing batch records and affiliated SOPs.
- Follow all applicable procedures, cGLP, cGMPs, and quality/regulatory requirements.
- Document and assess improvement opportunities from operators.
- Coordinate with area maintenance to schedule work orders for corrective maintenance.
- Lead Safety and Quality Investigations and author investigation reports.
- Collaborate cross-functionally to enable Foundry technology transfers.
- Serve as a key resource for operational improvement projects and initiatives.
- Plan and coordinate process campaign changeovers (cleandown, piping, maintenance, equipment setup); oversee execution to meet timelines.
- Work with PE, PTE, PRD, HSE, and Quality Assurance to ensure successful process transfer and execution.
- Apply Health/Safety/Process Safety standards; represent operations in Process Hazard Review (PHR) and other HSE venues.
- Promote continuous improvement of area changeover workflows.
Basic Requirements
- Bachelor’s or Associate’s degree in science/engineering/technical field, or HS Diploma/GED with 5+ years pharmaceutical manufacturing operations experience (Small Molecule, Biologics, or Mixed Modalities), including operations support, safety/quality incident investigations, authoring procedures/instructions, and process hazard reviews.
- Authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Preferences
- Pharmaceutical Product Research and Development experience.
- GMP experience supporting cleaning, changeover, and/or maintenance activities.
- Formal project management training; demonstrated leadership/influencing.
- Facility/area start-up experience.
- Solid understanding of FDA guidelines and cGMP requirements.
- Strong organizational skills; ability to troubleshoot/triage; understand technical nomenclature and math.
- Effective written, verbal, and electronic communication.
Other Information / Role Logistics
- Travel: ~5%.
- On-site, M–F schedule with flexibility to support 24/7 manufacturing operations nights and weekends as needed.
Benefits (as stated)
- Eligible for company bonus (company and individual performance).
- 401(k) eligibility; pension; vacation; medical/dental/vision/prescription; flexible benefits (e.g., healthcare/dependent day care FSAs); life insurance; time off/leave; well-being benefits (e.g., EAP, fitness, employee clubs).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation