Production Technician

Role Summary

Production Technician is on-site in Indianapolis, IN. This role supports daily production of Radioligand Therapies (RLT) and involves setup and preparation of instruments and equipment. The technician adheres to regulatory requirements and executes production per batch records and SOPs in a team-based environment, collaborating with the Manager and Lead to ensure safe and timely production. Shift is a 12-hour rotating schedule (6:00am–6:00pm) on weekdays with potential overtime.

Responsibilities

• Executes all activities related to the manufacturing of RLT products, including operating and maintaining grade A isolators, focusing on KPI goals and adherence to state, federal and Novartis radiation safety guidelines.
• Responsible for on-time completion of required training including SOPs, aseptic techniques, gowning qualifications, and other relevant training including HSE.
• Supports production readiness including manually cleaning the cell and sterilization of the isolators; conducts routine and dynamic environmental monitoring as required.
• Prepares materials while maintaining material identity in accordance with the batch monitoring system defined by procedure.
• Ensures all cGMP compliance activities are followed.
• Participates in qualification/validation activities and assists with deviation investigations and inspections as necessary.
• Prepares documents and records such as batch records, shipping documents, and training materials.

Qualifications

• Required: Bachelor’s degree in relevant Engineering or Scientific discipline is highly preferred; if no degree, a minimum of 1+ year of experience in cGMP or aseptic environment is required.
• Preferred: Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing.
• Required: Ability to gown aseptically and work in a clean room environment (Grade C) for extended periods.
• Required: Near vision performance equivalent to 20/20 with no impairment of color vision; corrective lenses permitted.
• Required: Ability to lift or carry up to 35 pounds.
• Preferred: Radio Pharma experience.
• Required: English language proficiency.

Skills

• Assembly Language
• Cooperation
• Efficiency
• Electronic Components
• Flexibility
• General HSE Knowledge
• Good Documentation Practice
• Installations (Computer Programs)
• ISO (International Organization For Standardization)
• Job Description
• Knowledge Of GMP
• Lean Manufacturing
• Manufacturing Process
• Manufacturing Production
• Nuclear Medicine
• Physics
• Product Distribution
• Production Line
• Scheduler

Education

• Bachelor’s degree in a relevant Engineering or Scientific discipline (preferred).

Additional Requirements

• Physical Demands: Ability to lift or carry up to 35 pounds.