Manufacturing Operator

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Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Organization Overview:

Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Position Brand Description:

The Manufacturing Operator is directly responsible for the production of API molecules used in Lilly medicines. The Operator will be responsible for upholding a safety-first, quality-always mindset in the production of API while running a production process that incorporates a wide range of unit operations.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), 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.

Responsibilities:

• Maintain compliance with regulatory requirements at all times.

• Support the execution of the production plan for the site.

• Carry out daily monitoring testing and cleaning duties as assigned to ensure equipment and systems are in good operating conditions and are maintained in accordance with local and corporate regulatory requirements.

• Understand Health, Safety & Environmental (HSE) requirements and the application of Health & Safety/Process Safety standards in order to execute GMP duties.

• Understand other area processes & their operational hazards and being able to react appropriately.

• Monitor and collect data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems.

• Work with Maintenance and Technical Support to respond appropriately to potential production upsets or equipment failure.

• Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing.

• Communicate with other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover.

• Participate in daily shift huddles / meetings to both understand and set expectations for daily operational goals.

• Actively participate in assigned building & area operations such as safety audits, procedure co-ordination, housekeeping and improvement projects.

• Be trained and qualified on all specified unit operations within the building.

• Identify concerns for informal or formal discussion (shift meetings, safety representative).

• Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.

• Must be able to use specified company supplied personal protective equipment (PPE) (e.g. hair & beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) for long periods of time.
  

Basic Requirements:

• High School Diploma or equivalent

• 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.

• Completion of Post Offer Exam or Completion of Work Simulation if applicable.

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

• Basic computer skills (desktop software) are required.

• Manual material handling as appropriate.

• Bend, reach, stretch, climb ladders, and work in tight spaces.

• Stand for long period.
  

Additional Preferences:

• Previous experience in facility/area start-up environments.

• Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals.

• 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 - ability to troubleshoot and triage challenges

• Ability to understand technical nomenclature and language as well as work with mathematical formulas.

• Emergency Response Experience
  • Industrial, military, volunteer, career firefighter
  • Indiana State or IFSAC Certification - Fire 1, Hazmat Technician
  

Additional Information:

• Ability to work 12-hour rotating shifts.

• Ability to work flexible schedules during startup period.

• Ability to work overtime as required.

• Depending on the candidate's experience, the position may require a short-term assignment of 1-3 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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