Scientist/Engineer, Technical Operations - Lilly Medicine Foundry
Eli Lilly and Company
19 days ago
On-site
Lebanon, IN
Operations
Key Responsibilities:
- Provide on-the-floor shift support for technical, training, and process support; execute production activities as needed.
- Evaluate processes/protocols and real-time deviations; provide assessments to cross-functional process teams.
- Execute equipment commissioning and qualification testing under C&Q; conduct and document production via digital manufacturing batch records and SOPs.
- Adhere to cGLP/cGMPs, policies, and quality/regulatory requirements.
- Document/assess operator improvement opportunities; coordinate corrective maintenance work orders.
- Lead safety and quality investigations; author investigation reports.
- Support technology transfers; serve as a resource for operational improvement projects.
- Create and execute project plans for changeover and new product introduction (cleandown, piping, maintenance, equipment setup).
- Coordinate with PE, PTE, PRD, HSE, and QA to successfully transfer and execute processes.
- Represent operations in PHRs and other HSE venues; promote continuous improvement of changeover workflows.
Basic Requirements:
- Bachelor’s or Associate’s degree in science/engineering/technical field, or HS Diploma/GED with 5+ years pharmaceutical manufacturing experience (Small Molecule, Biologics, or Mixed Modalities), including operations, safety/quality incident investigations, procedures/instructions, and PHRs.
- Authorization to work in the United States full-time (no visa sponsorship).
Additional Preferences:
- Product R&D experience; GMP cleaning/changeover/maintenance support.
- Formal project management training; leadership/influencing experience.
- Facility/area start-up experience; FDA/cGMP knowledge; lean principles.
- Ability to troubleshoot, understand technical nomenclature, work with mathematical formulas; strong communication.
Other:
- On-site M–F with flexibility for 24/7 coverage; ~5% travel.
- Location: initial Lilly Technology Center (Indianapolis) or Parkwood West (Carmel); permanent at Lilly Medicine Foundry (Lebanon, IN).
- Provide on-the-floor shift support for technical, training, and process support; execute production activities as needed.
- Evaluate processes/protocols and real-time deviations; provide assessments to cross-functional process teams.
- Execute equipment commissioning and qualification testing under C&Q; conduct and document production via digital manufacturing batch records and SOPs.
- Adhere to cGLP/cGMPs, policies, and quality/regulatory requirements.
- Document/assess operator improvement opportunities; coordinate corrective maintenance work orders.
- Lead safety and quality investigations; author investigation reports.
- Support technology transfers; serve as a resource for operational improvement projects.
- Create and execute project plans for changeover and new product introduction (cleandown, piping, maintenance, equipment setup).
- Coordinate with PE, PTE, PRD, HSE, and QA to successfully transfer and execute processes.
- Represent operations in PHRs and other HSE venues; promote continuous improvement of changeover workflows.
Basic Requirements:
- Bachelor’s or Associate’s degree in science/engineering/technical field, or HS Diploma/GED with 5+ years pharmaceutical manufacturing experience (Small Molecule, Biologics, or Mixed Modalities), including operations, safety/quality incident investigations, procedures/instructions, and PHRs.
- Authorization to work in the United States full-time (no visa sponsorship).
Additional Preferences:
- Product R&D experience; GMP cleaning/changeover/maintenance support.
- Formal project management training; leadership/influencing experience.
- Facility/area start-up experience; FDA/cGMP knowledge; lean principles.
- Ability to troubleshoot, understand technical nomenclature, work with mathematical formulas; strong communication.
Other:
- On-site M–F with flexibility for 24/7 coverage; ~5% travel.
- Location: initial Lilly Technology Center (Indianapolis) or Parkwood West (Carmel); permanent at Lilly Medicine Foundry (Lebanon, IN).