API Production Operator - Lilly Medicine Foundry

Eli Lilly and Company; Indianapolis (IN); On-site; USD 25,000 - 48,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Health, dental, vision benefits

Job summary

Eli Lilly and Company is seeking a Manufacturing Operator to support startup activities and bring manufacturing equipment into service across Small Molecule, Hybrid, or Biologics areas. This role requires travel to collaborate with sites that produce APIs and to oversee production after startup, with a safety-first, quality-always mindset.

The position demands 3+ years in API manufacturing, GMP familiarity, and the ability to work a 12-hour rotating shift.

Qualifications

• HS Diploma/GED required.
• 3+ years of API manufacturing experience; GMP and/or chemical processing experience preferred.
• Authorized to work in the United States; Lilly does not sponsor visas for this position.
• Understanding of FDA guidelines and cGMP requirements is a plus.

Responsibilities

• Adhere to safety, quality, and environmental requirements and troubleshoot adverse events.
• Operate processes and equipment per batch records, SOPs and design parameters to meet production schedule.
• Conduct daily monitoring, testing and cleaning to maintain equipment and systems per regulations.
• Apply Health, Safety & Environment (HSE) standards to GMP duties.
• Communicate with other shifts and participate in daily huddles to set operational goals.

Skills

API manufacturing

GMP

PSM

Lean manufacturing

FDA guidelines

Education

HS Diploma/GED

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization And Position Overview

In the project delivery phase and startup phase of the project, operational roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

The Lilly Medicine Foundry Manufacturing Operator actively supports start-up activities to bring manufacturing equipment into service. The Operator becomes an expert in their assigned area, Small Molecule, Hybrid, or Biologics, and educates the team on the proper operation of the facility. This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs.

Upon completion of the project phase, the Operator directly oversees the production of API molecules. The Operator ensures a safety-first, quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills.

Responsibilities

This role ensures the supply of our medicines by supporting the team, following instructions, assisting with troubleshooting, collaborating cross-functionally, and upholding our safety-first, quality-always mindset. Operators will support daily activities to meet production plans by:

• Adhering to compliance requirements (safety, quality, and environmental) and appropriately communicating/troubleshooting any adverse events.
• Operating processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet production schedule.
• Performing daily monitoring, testing, and cleaning duties to ensure equipment and systems are in good operating condition and maintained per local and corporate regulatory requirements.
• Understanding Health, Safety & Environmental (HSE) requirements and applying Health & Safety/Process Safety standards to execute GMP duties.
• Recognizing other area processes and their operational hazards and reacting appropriately.
• Monitoring and collecting data on equipment use and performance to anticipate potential reliability problems.
• Contacting the appropriate help if there is a problem or event (spill, deviation, incident) during manufacturing.
• Communicating with other shifts regarding the status of area operations and any issues/problems that have occurred at handover.
• Participating in daily shift huddles/meetings to understand and set expectations for daily operational goals.
• Actively participating in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
• Following cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
• Using specified company-supplied personal protective equipment (PPE) (e.g., hair and beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) as required.

Basic Requirements

• HS Diploma/GED
• 3+ years of API manufacturing experience, GMP and/or chemical processing preferred.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences

• Previous experience in facility or area start-up environments.
• Previous experience in a pharmaceutical or chemical manufacturing operation involving PSM-regulated or hazardous chemicals.
• 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.

Additional Information

• Position Location: US: Lebanon IN Lilly Medicine Foundry Operations initial location in Indianapolis, IN during pre-startup phase
• Travel Percentage: 5%
• Must be able to work a 12-hour rotating shift (3-2-2-3, rotating every 8 weeks between day and night shift).
• May be required to provide support outside of normal working hours including nights, weekends, and holidays.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $18.02 - $35.43

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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