2 x Production Technician - Night Shift
Novartis
Full-time
On-site
Indianapolis, IN
Operations
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Role Summary
This role is located on-site in Indianapolis, IN. Shift: Week Nights - Monday - Friday 1:00pm-10:00am. This position may involve mandatory overtime as needed. Production Technicians support daily production of Radioligand Therapies (RLT) and prepare instruments and equipment, adhering to regulatory requirements and performing production per batch records and SOPs.
Responsibilities
- Executes all activities related to the manufacturing of RLT products, operating and maintaining grade A isolators, and adhering to KPI goals and radiation safety guidelines.
- Complete training curriculum including SOPs, Aseptic Techniques, Gowning Qualifications, and other training including HSE.
- Support production readiness by cleaning cells and sterilizing isolators; conduct environmental monitoring as required.
- Prepare materials with identity maintained per batch monitoring system.
- Ensure all cGMP compliance activities are followed.
- Participate in qualification/validation activities and assist on deviation investigations and inspections as necessary.
- Prepare documents and records such as batch records, shipping documents, and training materials.
Qualifications
- Essential: Bachelor’s degree in Engineering or Scientific discipline preferred; or minimum 1+ year of experience in cGMP or aseptic environment.
- Knowledge of cGMP regulations and FDA guidance for aseptic manufacturing preferred.
- Ability to gown aseptically and work in a clean room (Grade C) for extended periods.
- Near vision equivalent to 20/20 with no color vision impairment; corrective lenses allowed.
- Ability to lift or carry up to 35 pounds.
- Radio Pharma experience preferred.
Skills
- Strong attention to regulatory compliance and safety guidelines
- Technical aptitude for operating and maintaining isolators and enabling sterile manufacturing
- Environmental monitoring and batch record management
- Documentation and record-keeping proficiency
Education
- Bachelor’s degree in a relevant Engineering or Scientific discipline (preferred)
Additional Requirements
- Shift: Nights - 12-hour rotating shift (6:00pm-6:00am); may require overtime.