Production Technician I (Weekend PM)

Healthcare Businesswomen’s Association; Indianapolis (IN); On-site; USD 52,000 - 98,000; Full time

Job summary

An established industry player is seeking dedicated Production Technicians to join their dynamic team in Indianapolis. This role involves active participation in the production of Radioligand Therapies, ensuring compliance with stringent safety and regulatory standards. You will work closely with experienced professionals, contributing to the manufacturing process while adhering to cGMP regulations. If you have a passion for science and a commitment to quality, this position offers a unique opportunity to make a significant impact in the field of nuclear medicine. Join a forward-thinking organization that values your expertise and dedication.

Qualifications

• Bachelor's degree preferred; 1+ year experience in cGMP or aseptic environment required.
• Knowledge of cGMP regulations and FDA guidance is highly preferred.

Responsibilities

• Execute manufacturing activities for RLT products and ensure compliance with safety guidelines.
• Complete training curricula including SOPs and Aseptic Techniques.

Skills

Assembly Language

Cooperation

Efficiency

Electronic Components

Flexibility

General HSE Knowledge

Good Documentation Practice

Installations (Computer Programs)

ISO Standards

GMP Knowledge

Lean Manufacturing

Manufacturing Process

Manufacturing Production

Nuclear Medicine

Physics

Product Distribution

Production Line

Scheduler

Education

Bachelor's degree in Engineering or Scientific discipline

1+ year of experience in a cGMP or aseptic environment

Job description

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.

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

Key Responsibilities:

1. Execute all activities related to manufacturing RLT products, including operating and maintaining grade A isolators, focusing on KPI goals, and ensuring compliance with all state, federal, and Novartis radiation safety guidelines.
2. Complete required training curricula, including SOPs, Aseptic Techniques, Gowning Qualifications, and other relevant training such as HSE.
3. Support production readiness by cleaning the cell, sterilizing isolators, and conducting environmental monitoring as required.
4. Prepare materials maintaining material identity according to batch monitoring systems.
5. Follow all cGMP compliance activities.
6. Participate in qualification/validation activities and assist with deviation investigations and inspections.
7. Prepare documents and records such as batch records, shipping documents, and training materials.

Shift: Week 1: Thurs-Sun, 6:00pm-6:00am; Week 2: Fri-Sun, 6:00pm-6:00am. This position may involve mandatory overtime as needed.

Essential Requirements:

1. Bachelor’s degree in Engineering or Scientific discipline is highly preferred; if not, a minimum of 1+ year of experience in a cGMP or aseptic environment is required.
2. Knowledge of cGMP regulations and FDA guidance related to aseptic manufacturing is highly preferred.
3. Ability to gown aseptically and work in a Grade C clean room environment for extended periods.
4. Near vision acuity of 20/20 (corrected lenses permitted) with no impairment of color vision.
5. Ability to lift or carry up to 35 pounds.
6. Radio Pharma experience is preferred.

Languages: English.

EEO Statement:

The Novartis Group of Companies is an Equal Opportunity Employer. We do not discriminate based on 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:

We are committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation during the application process or to perform job functions, please contact us at [e-mail] or call [phone]. Please include the job requisition number in your message.

Salary Range: $52,400.00 - $97,400.00

Skills Desired: Assembly Language, Cooperation, Efficiency, Electronic Components, Flexibility, General HSE Knowledge, Good Documentation Practice, Installations (Computer Programs), ISO Standards, GMP Knowledge, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Nuclear Medicine, Physics, Product Distribution, Production Line, Scheduler.