Job Description Summary
This role is located on-site in Indianapolis IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.Job Description
Key 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
Essential Requirements:
Bachelors 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
Desirable Requirements:
Radio Pharma experience preferred.
Languages :
English.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$52400.00 - $97400.00
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.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$52400.00 - $97400.00Skills 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 SchedulerRequired Experience:
IC
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.