Aseptic Trainer, AM Shift

Role Summary

The Aseptic Trainer (AM Shift) 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. This role provides aseptic technical training to the manufacturing cell processors, aseptic trainers, media technicians, and other CGT manufacturing related roles. This role provides support to the Aseptic Operations Training Program.

Responsibilities

• 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
• Demonstrate strong Aseptic Technique
• Deliver instructor-led and on-the-job training associated with Quality Systems, GMP Training requirements, and Aseptic qualifications
• Prepare and conduct hands-on QC Micro technical training and aseptic gowning training
• Support investigations and CAPAs related to aseptic processes within required timelines
• Maintain the training program in accordance with business needs, regulatory requirements, and Quality Management System
• 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 and communicate real-time training gaps to leads and training team, and provide on-going feedback
• Ensure effective knowledge transfer in relation to training activities
• Maintain processes to be inspection ready

Qualifications

• High school diploma with 2+ years of work experience in the GMP/pharmaceutical industry or equivalent
• 2+ years of related pharmaceutical technical training experience preferably in a production, QA, and/ or QC related role preferred.
• Direct experience working in a GMP and aseptic or sterile environment is required.
• Aseptic gowning and clean room experience is highly desired.
• Cell & gene therapy experience highly desired.

Skills

• Aseptic technique
• GMP and regulatory compliance
• Training delivery and materials development
• QA/QC, CAPA investigations
• Communication and real-time feedback

Education

• None specified beyond high school diploma; consider listing if relevant certifications exist

Additional Requirements

• Location: Onsite in Morris Plains, NJ
• Shift: 6:00 am ‚Äì 2:30 pm