Production Technician I

Healthcare Businesswomen’s Association; Millburn (NJ); On-site; USD 10,000 - 60,000; Full time

Job summary

A leading company is seeking a Production Technician to join their team in Millburn, NJ. This role involves the daily production of Radioligand Therapies, adhering to strict regulatory requirements. The technician will operate and maintain equipment, support production readiness, and participate in compliance activities. Candidates should have a relevant degree or experience in a cGMP environment. The position requires flexibility in shifts and may involve mandatory overtime.

Qualifications

• Minimum 1+ year experience in a cGMP or aseptic environment.
• Ability to gown aseptically and work in a Grade C clean room.

Responsibilities

• Execute manufacturing activities for RLT products and ensure compliance.
• Participate in qualification/validation activities and assist with inspections.

Skills

cGMP knowledge

Aseptic techniques

Environmental monitoring

Education

Bachelor’s degree in Engineering or Scientific discipline

Job description

Job Description Summary

#LI-Onsite

This role is located on-site in Millburn, NJ. 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.

Job Description

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 curricula, including SOPs, aseptic techniques, gowning qualifications, and other relevant training such as HSE.
3. Support production readiness by cleaning cells, sterilizing isolators, and conducting environmental monitoring.
4. Prepare materials maintaining their identity according to the batch monitoring system.
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:

Sun-Wed or Wed-Sat, AM Shift - 6am-6pm (12-hour rotating shifts). Flexibility on shift preference is preferred. Mandatory overtime may be required.

Essential Requirements:

1. Bachelor’s degree in Engineering or Scientific discipline is preferred; alternatively, a minimum of 1+ year experience in a cGMP or aseptic environment.
2. Knowledge of cGMP regulations and FDA guidance for aseptic manufacturing is 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 color vision impairment; corrective lenses permitted.
5. Ability to lift or carry up to 35 pounds.
6. Radio Pharma experience is preferred.

The pay range at start is expected to be between $27.79 and $51.59/hour. Salary may fluctuate based on market conditions, experience, and other factors. The total compensation may include bonuses, stock units, benefits, and other elements. Details will be provided upon offer.

Note: The company will not sponsor visas for this position.

Additional Information:

Commitment to Diversity & Inclusion: Novartis strives to build an inclusive, diverse work environment.

EEO Statement: We are an Equal Opportunity Employer, committed to non-discrimination.

Accessibility & Accommodations: We provide reasonable accommodations for individuals with disabilities. Contact us at [e-mail] or [phone].