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Operator - Production Technician
Operator - Production TechnicianEli Lilly and Company • Indianapolis, Indiana, United States
Operator - Production Technician

Operator - Production Technician

Eli Lilly and Company • Indianapolis, Indiana, United States
10 days ago
Job type
  • Full-time
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 39,000 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. #WeAreLilly

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company.

Responsibilities :

  • Perform manual, semi-automated, or automated visual inspection of finished pharmaceutical products (vials) to detect particulates, cosmetic defects, or container / closure integrity issues.
  • Apply defect classification criteria accurately and consistently in alignment with SOPs and regulatory standards.
  • Maintain aseptic technique and adhere to gowning procedures in classified cleanroom environments.
  • Accurately complete batch records, logbooks, and inspection documentation in compliance with ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles.
  • Segregate, label, and document rejected materials for quality review and disposition.
  • Support deviation reporting, CAPA activities, and root cause investigations related to inspection processes.
  • Operate, clean, and perform basic troubleshooting on inspection equipment.
  • Participate in qualification activities for new inspection processes, including media fills, training, and equipment validation.
  • Collaborate with QA, QC, and Manufacturing teams to ensure timely product release.
  • Contribute to continuous improvement efforts, including 5S, Lean, and process efficiency initiatives.

Basic Qualifications / Requirements :

  • High School diploma, certificate or a 2-year associate's degree in a science related field of study.
  • Prior qualification as a Visual Inspection Operator in a GMP-regulated environment.

    • Additional Skills / Preferences :

  • Strong understanding of GMP, GDP, and aseptic manufacturing principles. Strong documentation and communication skills.
  • Excellent attention to detail and ability to maintain focus for extended periods.
  • Ability to work in a cleanroom environment, including standing for long periods and repetitive hand / arm movements.
  • Proficiency in reading, understanding, and following SOPs, batch records, and inspection criteria
  • Familiarity with defect classification systems (critical, major, minor).
  • Experience with automated inspection technologies.
  • Aseptic production of radiopharmaceutical drug product in accordance with established manufacturing batch records.
  • Support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products and radioisotope products.
  • Investigate, resolve, and mitigate deviations, non-conformances, and OOS (Out of Specification) events associated with product manufacturing at the Lilly RLT GMP facility.
  • Monitor production-related equipment to ensure proper function and compliance with the established calibration / PM equipment schedule.
  • Continuous process improvement of existing manufacturing methods via Current Good Manufacturing Practices (cGMP).
  • Produce radioisotopes and drug products following cGMP guidelines and resolve all production-related quality events in a timely manner.
  • Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of drug products and radioisotopes.
  • Participate in technical transfer and process validation activities in collaboration with other departments.
  • Safely work with radioactive materials following ALARA principles and NRC guidelines.
  • Utilize and monitor all manufacturing-related equipment.
  • Conduct and appropriately document aseptic production of radiopharmaceutical drug product and radioisotopes via strict adherence to manufacturing batch records and affiliated SOPs.
  • Safely handle and participate in the transfer of radioactive materials throughout the facility.
  • Monitor manufacturing equipment to ensure performance and safety standards are met.
  • Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use.
  • Provide verbal and written reports to supervisors in a clear and concise manner.
  • Maintain accurate and complete lab data notebooks as per cGLP and / or cGMP, as appropriate.
  • Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.
  • Embody and promote a quality culture and due diligence approach as part of all activities.
  • Work well in a fast-paced team environment.
  • Perform other duties as assigned.
  • Experience working with radiopharmaceuticals will be considered an asset but is not a requirement.
  • Ability to maintain focus on a complex task for 4-6 hours at a time
  • Adaptable to work in a fast-paced and evolving environment
  • Maintain clear, consistent, and constant verbal communication with one or more team members during performance of duties
  • Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique
  • Full range of motion and ability to use both hands mandated by machinery. High degree of manual dexterity. Regular lifting of 10 lb weights, occasional lifting of up to 50 lbs
  • Excellent oral and written communication skills
  • Very detail oriented and meticulous with execution of tasks and documentation
  • Work collaboratively in a team environment
  • Operate and execute with a sense of urgency
  • Excellent organizational and interpersonal skills
  • Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)

    • Additional Information :

    This position’s work environment is on site at the 4850 W 78th St, Indianapolis Facility.

    Hours of work will require shift work, including weekend hours as we progress into the next phases of commercial manufacturing. Depending on the selected shift, the workweek will be 7AM-7PM or 7PM-7AM (2-2-3)

    Physical Demands / Travel :

    The physical demands of this job are consistent with a manufacturing environment .

    The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

    Work Environment :

    This position’s work environment is a manufacturing environment.

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  • To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

    • 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

    $18.02 - $34.90

    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

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