Scientist/Engineer

About the Role

The Lilly Medicine Foundry Manufacturing Scientist/Engineer – Technical Operations supports and potentially executes on-shift operations activities to ensure effective and consistent execution on the operation floor. This role provides on-floor operation execution working directly with operators, supports batch readiness and release, and works cross-functionally to provide technical and operational oversight to routine operations. The Scientist/Engineer – Technical Operations becomes an expert in their assigned area, Small Molecule, 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.

Initially, the Scientist/Engineer – Technical Operations will be responsible for supporting equipment qualification and site acceptance tests (SAT) while developing standard operating procedures and operator training plans. Upon completion of the project phase, the Scientist/Engineer – Technical Operations will provide technical oversight and ownership for the operations team providing on-the-floor training and process support, and leading incident investigations. This role plays a key technical role working collaboratively with the Process Translation and Execution (PTE), Processing Engineering (PE), and Product Research and Development (PRD) to prepare for effective delivery of our products. This role provides key technical input and participates in pre-startup activities such as Process Hazard Reviews (PHRs), development batch instructions, and support on-the-floor operations. The Scientist/Engineer could participate in performing routine manufacturing activities and may be on shift as needed in future operations. The Scientist/Engineer – Technical Operations ensures a safety-first, quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills.

Key Responsibilities

• Provide on-the-floor shift support for 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 judgment 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.
• May require domestic and international travel to collaborate, train, and learn from sites that currently produce APIs.

Requirements & Tech Stack

• Bachelor's or Associate's Degree in science, engineering, or technical field OR HS Diploma/GED with 5+ years of directly applicable manufacturing experience in pharmaceutical operations (Small Molecule, Biologics, or Mixed Modalities) including on the operations, incident investigations (safety and quality), authoring procedures/instructions, and process hazard reviews.

Qualifications

• 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.
• Ability to effectively communicate (electronically, written, and verbal).

Initial location at Lilly Technology Center, Indianapolis, or Parkwood West, Carmel, Indiana. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Travel Percentage: 5%

Position requires on-site presence on a M-F schedule, with flexibility to support operations activities in a 24/7 hour manufacturing environment during nights and weekends as needed.