Scientist/Engineer, Mixed Modality Technical Operations - Lilly Medicine Foundry

The Scientist/Engineer – Technical Operations becomes an expert in their assigned area, Small Molecule, Hybrid, or Biologics, and serves as a key integrator with Process Engineering, Process Translation and Execution (PTE), and Product Research and Development (PRD) in introducing new processes into the plant. In the pre-startup phase, the role will contribute heavily to Operational Readiness activities for the new facility supporting technical processes, tech transfer, operational readiness, delivery of trainings, procedures, and workflows.

Key Responsibilities

• Provide on the floor shift support for the operations staff for technical, training, and process support and at times execute production activities.
• Leverage problem solving skills to evaluate process & protocols, deviations real-time and provide assessments to cross functional process teams.
• Apply independent judgement and discretion to execute equipment commissioning and qualification testing under the guidance of the C&Q.
• Conduct and appropriately document production via adherence to digital manufacturing batch records and affiliated SOPs.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
• Ensure improvement opportunities from Operators are appropriately documented and assessed.
• Work with area maintenance to schedule work orders for corrective maintenance.
• Lead Safety and Quality Investigations and author investigation reports.
• Cross-functional collaboration to enable Foundry technology transfers.
• Serve as a key resource for operational improvement projects and other initiatives.
• Partner with functional groups to prepare for process campaigns creating project plans for changeover execution, including optimized approaches for cleandown, piping, maintenance, and equipment setup execution.
• Coordinate and oversee project execution to meet desired timelines.
• Work cross-functionally with PE, PTE, PRD, HSE, and Quality Assurance to ensure processes are transferred and executed successfully in the Foundry.
• Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards and represent operations in Process Hazard Review (PHR) meetings and other HSE-related venues.
• Promote continuous improvement of area changeover workflows to make changeovers easier or more efficient.
• Collaborate in a fast paced team environment.

Basic Requirements

• Bachelor’s or Associate's Degree in science, engineering; OR technical field or HS Diploma/GED with 5+ years of directly applicable manufacturing experience pharmaceutical operations (Small Molecule, Biologics, or Mixed Modalities) including on the operations, incident investigations (safety and quality), authoring procedures/instructions, and process hazard reviews.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

Additional Preferences

• Experience in Pharmaceutical Product Research and Development a plus
• Experience providing technical and/or coordination support toward cleaning, changeover, and/or maintenance activities in a GMP production environment
• Formal project management training considered a plus
• Demonstrated leadership and influencing experience
• Previous experience in facility or area start-up environments.
• A solid understanding of FDA guidelines and cGMP requirements.
• Strong organizational skills with the ability to handle and prioritize multiple requests.
• Knowledge of lean manufacturing principles.
• Flexibility to troubleshoot and triage challenges effectively.
• The ability to understand technical nomenclature and language, as well as work with mathematical formulas.
• Ability to effectively communicate (electronically, written and verbal).