Production Technician

4 days ago

New York, New York, United States Novartis Full time

Job Summary

This role is located on-site in Millburn, NJ. Novartis is committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are seeking an experienced Manufacturing professional to join our team.

Key Responsibilities:

  • Execute all activities related to the manufacturing of RLT products, ensuring compliance with regulatory requirements and company standards.
  • Operate and maintain grade A isolators, focusing on KPI goals and ensuring adherence to state, federal, and Novartis radiation safety guidelines.
  • Support all technical aspects related to production readiness, including manual cleaning of the cell and sterilization of isolators.
  • Conduct routine and dynamic environmental monitoring as required.
  • Prepare all materials while maintaining material identity in accordance with the batch monitoring system.
  • Ensure all cGMP compliance activities are followed.
  • Participate in assigned qualification/validation activities and assist with deviation investigations and inspections as necessary.
  • Prepare applicable documents and records, such as batch records, shipping documents, and training materials.

Requirements:

  • Bachelor's degree in a relevant Engineering or Scientific discipline is highly preferred; 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.
  • Ability to lift or carry up to 35 pounds.
  • Radio Pharma experience is preferred.

Pay Range: $59,900.00 - $89,900.00

Skills Desired: 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

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