Scientist/Engineer, Biologics Technical Operations - Lilly Medicine Foundry

Lilly • Indianapolis, IN

4d • $67,500 - $151,800 • Onsite

About The Position

The Scientist/Engineer – Technical Operations supports and may execute shift operations to ensure effective, consistent work on the manufacturing floor. The role provides direct support to operators, helps prepare and release batches, and offers technical and operational oversight of routine operations. The position develops expertise in an assigned area—Small Molecule, Hybrid, or Biologics—and integrates with Process Engineering, Process Translation and Execution (PTE), and Product Research and Development (PRD) to introduce new processes into the plant.

Representing operations, the Scientist/Engineer leads detailed planning for process changeovers and new product introduction. Before startup, the role contributes to operational readiness, technical processes, technology transfer, training, procedures, and workflows. Initial responsibilities include supporting equipment qualification and site acceptance tests (SAT), and developing standard operating procedures and operator training plans. After the project phase, the role provides technical ownership and oversight for the operations team, including floor-based training and process support, and leading incident investigations.

The position collaborates with PTE, Processing Engineering (PE), PRD, HSE, and Quality Assurance to prepare for product delivery and successful process transfer. It provides technical input to pre-startup activities such as Process Hazard Reviews (PHRs) and development batch instructions, and supports operations on the floor. The role may perform routine manufacturing activities and may work shifts as needed in future operations. It requires a safety-first, quality-always approach to production processes involving diverse unit operations and manufacturing skills. Domestic and international travel may be required to collaborate with, train at, and learn from sites that currently produce APIs.

The initial work location is Lilly Technology Center in Indianapolis or Parkwood West in Carmel, Indiana; the permanent location will be the Lilly Medicines Foundry in Lebanon, Indiana. The role is onsite on a Monday–Friday schedule, with flexibility to support operations in a 24/7 manufacturing environment, including nights and weekends as needed. Travel is approximately 5%.

Requirements

• Bachelor’s or Associate’s degree in science, engineering, or a technical field; alternatively, a high school diploma or GED with 5 or more years of directly applicable pharmaceutical manufacturing experience.
• For the experience-based education alternative, applicable experience must include pharmaceutical operations in Small Molecule, Biologics, or Mixed Modalities, including operations, safety and quality incident investigations, authoring procedures or instructions, and process hazard reviews.
• Must be authorized to work in the United States on a full-time basis; the employer will not sponsor work authorization or visas for this role.
• Ability to work onsite Monday through Friday and flexibly support operations in a 24/7 manufacturing environment, including nights and weekends as needed.
• Ability to travel domestically and internationally as required.

Nice To Haves

• Experience in Pharmaceutical Product Research and Development.
• Experience providing technical or coordination support for cleaning, changeover, or maintenance activities in a GMP production environment.
• Formal project management training.
• Demonstrated leadership and influencing experience.
• Previous experience in facility or area startup environments.
• Solid understanding of FDA guidelines and cGMP requirements.
• Strong organizational skills and ability to handle and prioritize multiple requests.
• Knowledge of lean manufacturing principles.
• Flexibility to troubleshoot and triage challenges effectively.
• Ability to understand technical nomenclature and language and work with mathematical formulas.
• Ability to communicate effectively electronically, in writing, and verbally.

Responsibilities

• Provide on-floor shift support to operations staff for technical, training, and process needs, and at times execute production activities.
• Evaluate processes, protocols, and deviations in real time and provide assessments to cross-functional process teams.
• Use independent judgment to execute equipment commissioning and qualification testing under C&Q guidance.
• Conduct and document production activities in accordance with digital manufacturing batch records and associated SOPs.
• Follow applicable procedures, cGLP, cGMPs, company policies, and other quality or regulatory requirements.
• Ensure improvement opportunities identified by operators are documented and assessed.
• Work with area maintenance to schedule corrective maintenance work orders.
• Lead safety and quality investigations and author investigation reports.
• Collaborate across functions to enable Foundry technology transfers.
• Serve as a resource for operational improvement projects and other initiatives.
• Partner with functional groups to plan process campaigns and changeover execution, including cleandown, piping, maintenance, and equipment setup.
• Coordinate and oversee project execution to meet timelines.
• Work with PE, PTE, PRD, HSE, and Quality Assurance to ensure processes are transferred and executed successfully in the Foundry.
• Apply health, safety, and process safety standards; represent operations in PHR meetings and other HSE-related venues.
• Improve area changeover workflows to make changeovers easier or more efficient.
• Collaborate in a fast-paced team environment.

Benefits

• Company bonus eligibility, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefit eligibility.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree