Newark Metro Area, NJ
Coach and train manufacturing operators for Aseptic Operator Qualifications within the clean room. Work with trainees on the required skills and materials to perform their jobs aseptically and efficiently. Qualify operators to work aseptically in the biosafety cabinet (ISO5/Grade A).
Position may require aseptic gowning (no skin exposure) and training operations in the clean room environment for a full workday
Continuously evaluate and provide improvements to the Aseptic/Technical training program
Oversee and maintain training equipment, material and training environment
Coach, mentor and train on aseptic technique related to gowning for Grade B (ISO 7) and environmental monitoring (MetOne, SAS, Contact Plates)
Conduct aseptic operations classroom training: aseptic gowning, cleanroom behavior, contamination control, etc.
Conduct hands-on, practical aseptic gowning training. Evaluate trainee's ability to gown-up aseptically
Conduct BSC cleaning training
Reinforce good documentation practices and Data Integrity requirements
Ensure effective knowledge transfer
Ability to gown-up aseptically to enter Grade B cleanroom
Ability to conduct engaging instructor-led/classroom training for groups of up to 20 trainees
Working knowledge of environmental monitoring equipment (particulate counter, SAS sampler)
Strong verbal and written communication with ability to communicate complex ideas and concepts
Demonstrate Strong Aseptic technique
Technical trainer capabilities
Coaching and feedback experience
Bachelor's degree in a scientific field with 2 - 5 years of GMP /pharmaceutical work experience or 1 - 3 years of Aseptic clean room experience.
Experience with aseptic media filling preferred.