Production Technician I - Week Day

Role Summary

Production Technician I - Week Day is an on-site role located in Indianapolis, IN. The position involves daily production of Radioligand Therapies (RLT), setup and preparation of instruments and equipment, and adherence to regulatory requirements and SOPs. Works within a team and aligns with a rotating 12-hour shift schedule to ensure safe and timely production.

Responsibilities

• Executes all activities related to the manufacturing of RLT products, including operating and maintaining grade A isolators and adhering to KPI goals and radiation safety guidelines.
• Completes required training curriculum (SOPs, Aseptic Techniques, Gowning Qualifications, and relevant training including HSE).
• Supports production readiness through cell cleaning and sterilization of isolators; conducts environmental monitoring as required.
• Prepares materials while maintaining material identity per batch monitoring procedures.
• Ensures cGMP compliance activities are followed.
• Participates in qualification/validation activities and assists with deviation investigations and inspections as needed.
• Prepares documents and records such as batch records, shipping documents, and training materials.

Qualifications

• Required: Bachelor‚Äôs degree in a relevant engineering or scientific discipline is highly preferred; if no degree, a minimum of 1+ year of experience in a cGMP or aseptic environment.
• Required: Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing is highly preferred.
• Required: Ability to gown aseptically and work in a clean room (Grade C) for extended periods.
• Required: Near vision equivalent to 20/20 with no color vision impairment; corrective lenses allowed.
• Required: Ability to lift or carry up to 35 pounds.

Skills

• Good Manufacturing Practice (GMP) knowledge
• Lean manufacturing, production processes, and quality documentation
• Understanding of ISO standards and nuclear medicine concepts
• Equipment operation and maintenance in a sterile environment
• Strong attention to detail and collaboration within a team

Education

• Relevant bachelor‚Äôs degree (engineering or scientific discipline) preferred; alternative with 1+ year cGMP/aseptic experience

Additional Requirements

• Shift: 12-hour rotating shift (Mon-Wed, Mon-Thu next week) 6:00am-6:00pm; may require overtime