Job Description SummaryThe Aseptic Trainer, AM Shift, is 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 and support to the manufacturing cell
processors, aseptic trainers, media technicians, and other CGT manufacturing related roles.
This is an onsite position located in Morris Plains, NJ. Novartis is unable to offer relocation support for this role. Please only apply if the location is accessible for you. The working hours are 6:00a-2:30p.
Job DescriptionMajor accountabilities:
- Coach, mentor, and train cell processors, technical trainers, and aseptic trainers on the required skills and materials to perform their jobs efficiently
- Deliver instructor-led and on-the-job training associated with Quality Systems, GMP Training requirements
- Prepare and conduct hands-on QC micro technical training and aseptic gowning training
- Maintain and support the scheduling of technical training activities including delivery of all required training for the manufacturing process (e.g. classroom instruction, systems training, etc.)
- Maintain the training program in accordance with business needs, regulatory requirements, and Quality Management System
- Assist in the development and / or review developed training materials for technical accuracy, regulatory compliance, and effectiveness
- Demonstrate strong Aseptic Technique
- 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
Requirements:
- 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 preferred.
- Cell & gene therapy experience highly desired.
- Foster & support a team culture that is engaged and empowered
EEO Statement:The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility and reasonable accommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [redacted] or call +[redacted] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range$84,000.00 - $126,000.00
Skills DesiredChange Control, Chemical Engineering, Continual Improvement Process, Efficiency, Employment Discrimination, Flexibility, General Hse Knowledge, Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Physics, Process Control, Production Line, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Technology Transfer, Well-Being
