Scientist/Engineer – Technical Operations - Lilly Medicine Foundry

About the role

The Lilly Medicine Foundry is a new center for advanced manufacturing and drug development, combining research and manufacturing in a single location. The Scientist/Engineer – Technical Operations supports and potentially executes on shift operations activities to ensure effective and consistent execution on the operation floor.

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.
• Career development and professional growth opportunities within the Lilly Medicine Foundry.

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.
• Authorized to work in the United States on a full-time basis.
• Experience in Pharmaceutical Product Research and Development.
• 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.
• Able to effectively communicate (electronically, written and verbal).