Production Technician

Novartis•Indianapolis, IN

102d•Onsite

About The Position

Production Technicians play an active role in daily production of Radioligand Therapies (RLT) as well as setup and preparation of instruments and equipment. The Production Technician adheres to regulatory requirements while performing job functions, executing production as per batch records and SOPs. Responsibilities are performed within a team and according to an assigned production shift schedule. The Production Technician works closely with the Manager and Lead to ensure production is executed in a safe and timely manner.

Requirements

Bachelor’s degree in relevant Engineering or Scientific discipline is highly preferred; If the applicant does not have a degree, a minimum of 1+ year’ of experience in cGMP or aseptic environment is required.
Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing is highly preferred.
Ability to gown aseptically and work in a clean room environment (Grade C) area for extended periods of time is required.
Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.
Ability to lift or carry up to 35 pounds

Nice To Haves

Radio Pharma experience preferred.
Languages : English.

Responsibilities

Executes all activities related to the manufacturing of RLT products.
Responsibilities include operating and maintaining grade A isolators, focusing on KPI goals as well as ensuring all state, federal and Novartis radiation safety guidelines are adhered to.
Responsible for successful on-time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators.
Conducts routine and dynamic environmental monitoring as required.
Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
Ensures all cGMP compliance activities are followed.
Participation in assigned qualification/validation activities, and assist on deviation investigations and inspections, as necessary.
Prepares applicable documents and records such as batch records, shipping documents, and training materials.
Shift: 12-hour rotating shift. Monday - Wednesday, Monday -Thursday the following week, 6:00am-6:00pm. This position may involve mandatory overtime as needed