Production Technician I (Weekend PM)

National Black MBA Association; Indianapolis (IN); On-site; USD 52,000 - 98,000; Full time

Job summary

A leading company is seeking Production Technicians to join their team in Indianapolis. This role involves executing production tasks for Radioligand Therapies, ensuring compliance with safety guidelines, and maintaining high standards in a clean room environment. Ideal candidates will have a background in engineering or a scientific discipline and experience in a cGMP setting. The position requires teamwork and adherence to strict protocols for successful production operations.

Qualifications

• 1+ year of experience in a cGMP or aseptic environment required.
• Knowledge of cGMP regulations and FDA guidance preferred.

Responsibilities

• Execute activities related to manufacturing of RLT products.
• Support production readiness by cleaning cells and conducting monitoring.
• Prepare documents and records such as batch records and training materials.

Skills

Cooperation

Efficiency

Flexibility

Good Documentation Practice

GMP Knowledge

Lean Manufacturing

Nuclear Medicine

Physics

Education

Bachelor’s degree in a relevant Engineering or Scientific discipline

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. 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.

Key Responsibilities:

1. Execute all activities related to the manufacturing of 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 curriculum, including SOPs, aseptic techniques, gowning qualifications, and other relevant training such as HSE for the specific role.
3. Support production readiness by cleaning cells, sterilizing isolators, and conducting routine and dynamic environmental monitoring as required.
4. Prepare materials while maintaining material identity according to batch monitoring systems and procedures.
5. Ensure all cGMP compliance activities are followed.
6. Participate in qualification/validation activities, assist in deviation investigations, and support inspections as necessary.
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 a relevant Engineering or Scientific discipline is highly preferred; alternatively, a minimum of 1+ year of experience in a cGMP or aseptic environment is required.
2. Knowledge of cGMP regulations and FDA guidance applicable 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 performance equivalent to 20/20, with no impairment of color vision; corrective lenses are permitted.
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 other legally protected statuses.

Accessibility and Reasonable Accommodations:

The Novartis Group of Companies is committed to providing reasonable accommodations for 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]. 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 (International Organization for Standardization), GMP Knowledge, Lean Manufacturing, Manufacturing Process, Production Line, Nuclear Medicine, Physics, Product Distribution, Production Scheduling.