Novartis Pharma Schweiz
Production Technician, Weekend Nights
Novartis Pharma Schweiz, Indianapolis, Indiana, us, 46262
Production Technician, Weekend Nights
Company: Novartis Pharma Schweiz
Production Technicians play an active role in daily production of isotope manufacturing 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 Production Lead and Shift Supervisor to ensure production is executed in a safe and timely manner.
Major Accountabilities
Executes all activities related to the manufacturing of RLT isotope products.
Operate and maintain grade C isolators, focusing on KPI goals while ensuring all state, federal and Novartis radiation safety guidelines are adhered to.
Responsible for successful on‑time completion of required training curriculum comprising the necessary Standard Operating Procedures (SOPs), Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
Support all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators.
Conduct routine and dynamic environmental monitoring as required.
Prepare all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
Participate in assigned qualification/validation activities, as necessary.
Facilitate a culture of “speaking up” and ensuring all cGMP compliance activities are followed.
Prepare applicable documents and records such as batch records, shipping documents, and training materials.
Particip to ensure process continuity and completion.
Other duties may be assigned, as necessary.
Requirements
Training in radiochemistry or radio pharmacy is preferred.
2+ years of experience in pharmaceutical manufacturing, with low bioburden manufacturing preferred.
Good understanding of manufacturing and validation requirements and activities.
Exploitation of new technology and techniques to eliminate non‑value adding activities and improve productivity / performance through new processes.
Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
Proficient in MS Office applications.
Flexibility to don clean room garments and personal protective equipment (PPE).
Near vision performance equivalent to 20/20 with no impairment of color vision. Corrective lenses to achieve desired visual acuity are permitted.
Makeup, jewelry, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.
Ability to lift or carry up to 35 pounds.
Employment Details
Seniority level: Entry level
Employment type: Full‑time
Job function: Management and Manufacturing
Industry: Pharmaceutical Manufacturing
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Production Technicians play an active role in daily production of isotope manufacturing 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 Production Lead and Shift Supervisor to ensure production is executed in a safe and timely manner.
Major Accountabilities
Executes all activities related to the manufacturing of RLT isotope products.
Operate and maintain grade C isolators, focusing on KPI goals while ensuring all state, federal and Novartis radiation safety guidelines are adhered to.
Responsible for successful on‑time completion of required training curriculum comprising the necessary Standard Operating Procedures (SOPs), Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
Support all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators.
Conduct routine and dynamic environmental monitoring as required.
Prepare all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
Participate in assigned qualification/validation activities, as necessary.
Facilitate a culture of “speaking up” and ensuring all cGMP compliance activities are followed.
Prepare applicable documents and records such as batch records, shipping documents, and training materials.
Particip to ensure process continuity and completion.
Other duties may be assigned, as necessary.
Requirements
Training in radiochemistry or radio pharmacy is preferred.
2+ years of experience in pharmaceutical manufacturing, with low bioburden manufacturing preferred.
Good understanding of manufacturing and validation requirements and activities.
Exploitation of new technology and techniques to eliminate non‑value adding activities and improve productivity / performance through new processes.
Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
Proficient in MS Office applications.
Flexibility to don clean room garments and personal protective equipment (PPE).
Near vision performance equivalent to 20/20 with no impairment of color vision. Corrective lenses to achieve desired visual acuity are permitted.
Makeup, jewelry, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.
Ability to lift or carry up to 35 pounds.
Employment Details
Seniority level: Entry level
Employment type: Full‑time
Job function: Management and Manufacturing
Industry: Pharmaceutical Manufacturing
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