Scientist​/Engineer, Technical Operations - Lilly Medicine Foundry

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.

• 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).

• 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.

• 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).