Operator - Production Technician

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).