Aseptic Manufacturing Trainer

Description

• Support investigations and CAPAs related to aseptic processes within required timelines
• Continuously evaluate and provide improvements on the aseptic training program. Assist in the development and / or review developed training materials for technical accuracy, regulatory compliance, and effectiveness
• Monitor, coach, mentor, and train cell processors, media technicians, technical trainers, aseptic trainers, and other shop floor personnel on the required skills and materials to perform their jobs efficiently
• Prepare and conduct hands-on QC Micro technical training and aseptic gowning training
• Deliver instructor-led and on-the-job training associated with Quality Systems, GMP Training requirements, and Aseptic qualifications
• Monitor and communicate real-time training gaps to leads and training team, and provide on-going feedback
• The Aseptic Trainer will be responsible for the maintenance and delivery of the technical training associated with the entire Cell and Gene Therapy Organization (CG&T) manufacturing program.
• Ensure effective knowledge transfer in relation to training activities
• This role provides support to the Aseptic Operations Training Program.
• Maintain the training program in accordance with business needs, regulatory requirements, and Quality Management System
• This role provides aseptic technical training to the manufacturing cell processors, aseptic trainers, media technicians, and other CGT manufacturing related roles.

Requirements

• Bachelor’s Degree within the Sciences
• 2+ years of related pharmaceutical technical training experience preferably in a production, QA, and/ or QC related role preferred.
• Demonstrate strong Aseptic Technique
• Aseptic gowning and clean room experience is highly desired.
• Direct experience working in a GMP and aseptic or sterile environment is required.
• 2+ years of work experience in the GMP/pharmaceutical industry or equivalent

Benefits

• Employee Assistance Program
• Transportation benefits
• Critical Illness, Accident, and Hospital
• Short and long-term disability
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Jan 19, 2026.
• Health Spending Account (HSA)
• Medical, dental & vision

Training + Development

Interview process

Visa Sponsorship

Security clearance