Scientist/Engineer, Technical Operations - Lilly Medicine Foundry
Eli Lilly and Company
19 days ago
On-site
Indianapolis, IN
Operations
Key Responsibilities:
- Provide on-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 (under C&Q guidance) and conduct work with proper documentation (digital manufacturing batch records and SOPs).
- Adhere to cGLP/cGMP, cGMPs, company policies, and quality/regulatory requirements.
- Document and assess operator improvement opportunities; coordinate corrective maintenance with area maintenance.
- Lead safety and quality investigations; author investigation reports.
- Support Foundry technology transfers; serve as a resource for operational improvement projects.
- Plan and coordinate process campaigns/changeover execution (cleandown, piping, maintenance, equipment setup) and oversee execution to meet timelines.
- Work cross-functionally with PE, PTE, PRD, HSE, and Quality Assurance to transfer and execute processes successfully.
- Apply Health, Safety & Environmental/process safety standards; represent operations in PHR and HSE venues.
- Promote continuous improvement of changeover workflows; collaborate in a fast-paced team environment.
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, safety/quality incident investigations, authoring procedures/instructions, and process hazard reviews.
- Authorization to work in the U.S. on a full-time basis (no visa sponsorship).
Additional Preferences:
- Pharma product R&D experience; GMP cleaning/changeover/maintenance technical/coordination support.
- Formal project management training; leadership/influencing experience.
- Start-up environment experience; FDA/cGMP knowledge; lean manufacturing knowledge.
- Troubleshooting/triage, technical communication, and ability to work with technical nomenclature and mathematical formulas.
Benefits (if applicable): eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being.
Other Information:
- On-site M-F schedule; flexibility for 24/7 operations as needed; travel ~5%.
- Initial location in Indianapolis/Carmel; permanent location in Lebanon, IN.
- Provide on-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 (under C&Q guidance) and conduct work with proper documentation (digital manufacturing batch records and SOPs).
- Adhere to cGLP/cGMP, cGMPs, company policies, and quality/regulatory requirements.
- Document and assess operator improvement opportunities; coordinate corrective maintenance with area maintenance.
- Lead safety and quality investigations; author investigation reports.
- Support Foundry technology transfers; serve as a resource for operational improvement projects.
- Plan and coordinate process campaigns/changeover execution (cleandown, piping, maintenance, equipment setup) and oversee execution to meet timelines.
- Work cross-functionally with PE, PTE, PRD, HSE, and Quality Assurance to transfer and execute processes successfully.
- Apply Health, Safety & Environmental/process safety standards; represent operations in PHR and HSE venues.
- Promote continuous improvement of changeover workflows; collaborate in a fast-paced team environment.
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, safety/quality incident investigations, authoring procedures/instructions, and process hazard reviews.
- Authorization to work in the U.S. on a full-time basis (no visa sponsorship).
Additional Preferences:
- Pharma product R&D experience; GMP cleaning/changeover/maintenance technical/coordination support.
- Formal project management training; leadership/influencing experience.
- Start-up environment experience; FDA/cGMP knowledge; lean manufacturing knowledge.
- Troubleshooting/triage, technical communication, and ability to work with technical nomenclature and mathematical formulas.
Benefits (if applicable): eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being.
Other Information:
- On-site M-F schedule; flexibility for 24/7 operations as needed; travel ~5%.
- Initial location in Indianapolis/Carmel; permanent location in Lebanon, IN.