Healthcare Businesswomen’s Association
Aseptic Trainer, PM Shift
Healthcare Businesswomen’s Association, Morris Plains, New Jersey, us, 07950
Job Description Summary
The Aseptic Trainer (PM 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.
Job Description The Aseptic Trainer (PM 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.
Location 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.
Shift The working hours for this role will be 1:00 pm – 9:30 pm
Key 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
Essential 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 highly desired.
Cell & gene therapy experience highly desired.
Novartis Compensation and Benefit Summary The salary for this position is expected to range between $77,000 and $143,000 annually.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. 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.
Accessibility and reasonable accommodations The 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 us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired Change 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
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Job Description The Aseptic Trainer (PM 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.
Location 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.
Shift The working hours for this role will be 1:00 pm – 9:30 pm
Key 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
Essential 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 highly desired.
Cell & gene therapy experience highly desired.
Novartis Compensation and Benefit Summary The salary for this position is expected to range between $77,000 and $143,000 annually.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. 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.
Accessibility and reasonable accommodations The 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 us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired Change 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
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