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.

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

$17.30 - $28.85

Position Title: Operator, Senior Operator, Expert Operator

Job Classification: B1-B3

Technical position: Yes

Purpose:

This position is part of the Bioprocess Research & Development (BR&D) organization and supports the K360 clinical trial pilot plant (CTPP).  There are five primary operational areas within K360.  Examples of the activities associated with each area are listed below:

MakeupMake buffers and media from various raw materials.Perform in-process tests of media and buffersClean equipment with clean-in-place cycles and in cabinet washersFill media and buffer into process containersInoculation LabDevelop inoculum for microbial and mammalian culture productsPerform bioburden testing for the bioreactors and media operationsSubmit samples to third-parties for further evaluation.Cell Culture/Primary RecoveryTransfer inoculum from the inoculation lab to the bioreactors/fermentersMonitor, feed, and harvest feed cell cultureClean equipment with clean-in-place cycles and in cabinet washersSteam equipment with steam-in-place cyclesPurificationPurify harvested material with various purification techniques (chromatography, viral filtration, tangential flow filtration, etc.).Fill the final active pharmaceutical ingredient (API) into storage containersClean equipment with clean-in-place cycles and in cabinet washersRaw Material DispensingPerforms dispensing activities supporting the manufacture of APIReceive incoming shipments of raw materialOversee raw material inventory and ensure the dispensing area delivers orders in a timely mannerPerform general housekeeping of the area

Location:  LTC-North: B360

Specific Functions or Duties

The primary responsibilities of the position require:

Technical Ability: The Operator must be able to operate and monitor process equipment and related systems in accordance with approved tickets and procedures.  In addition, he/she must be willing to accept new assignments, projects, and challenges as assigned by supervision, be capable of troubleshooting issues as they occur, and identify trends and ways to reduce process variability.

Data Management/Compliance: The Operator must exhibit a high level of attention to detail and a quality-minded approach to all record keeping.  Accurate and legible records must be maintained and analyzed to provide detailed information on the status of their operations.  All documentation must comply with cGMP practices as defined by Corporate, Divisional, and Local procedures/tickets, policies and practices. 

Communication Skills, Oral and Written: This position may require interaction with, but not limited to; Quality Team members, Bioproduct Research and Development scientists, Analytical Services, Operations, Technical Services Representatives, Engineering, and Maintenance personnel.  In addition, the Operator must be able to effectively communicate and understand technical information with regards to his/her area. 

Safety and Environmental Awareness: The Operator shall be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.

Minimum Qualification Requirements: 

2+ years experience relevant to their area (makeup, inoc, MCC, purification, raw material dispensing, etc.) or 2 year degree in biotechnologyStrong cGMP background; specific experience required in a regulated environment where both quality and safety regulations are being addressed on a daily basis  Experience executing manufacturing tickets, following procedures and completing engineering protocols including the use of Word and Excel.Ability to interact and build effective relationships with a wide range of groups including:  HSE, Quality Control, Tech Services, Development Scientists, Operations, Validation (C&Q), Automation, Engineering, Maintenance, and Environmental Monitoring.

Required Certifications:

N/A

Additional Preferences: 

5+ years experience relevant to their area (makeup, inoc, MCC, purification, raw material dispensing, etc.)Experience with computer systems such as SAP, Regulus/Syncade, Trackwise, Discoverant and LIMS Systems.Experience operating process control systems (DeltaV, Unicorn) and using process historians (PI, Unicorn)General interpersonal and communication skills; coaching, feedback, training, and fostering an environment for learning and open/honest communication.Basic analytical and problem-solving skills.

Personal Considerations:

Work environment includes administrative and production settings.Safety glasses, safety shoes, and appropriate gowning, such as Tyvek suits, are required in production areas.

Other Information:

Shifts can vary for each area.  Flexibility is required to accommodate different production shifts, possibly including night work.

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 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.

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.

#WeAreLilly