Technical Trainer - Cell Gene Therapy Manufacturing

Minaris • Allendale, NJ

2d • Hybrid

About The Position

Serves as primary technical trainer to facilitate and conduct on-the-job training for the effective induction of new hires, as well as the ongoing improvement and proficiency (i.e.; cross-training) of personnel within the department, by delivering on-the-job technical training on a timely basis. Demonstrates knowledge of learning and development delivery in an aseptic cell therapy manufacturing environment. Evaluates job proficiency and skills while correcting and coaching workmanship and technique by completing personnel evaluations or proficiency assessments during production activities. Actively monitors personnel’s technique and application of learning and provides feedback to trainees as well as to managers. Facilitates timely resolution and closeout of corrective and preventative actions specific to technical training. Responsible for the creation and revision of Unit Operation Training for Onboarding Skillsets, including User Manuals, Instructor Manuals, Instructor Led Trainings (ILT), On the Job trainings, Videos, and Final Assessments in collaboration with site partners. Also responsible for the creation and revision of Client Specific training content, including User Manuals, Instructor Manuals, Instructor Led Trainings (ILT), On the Job trainings, Videos, and Final Assessments in collaboration with Subject Matter Experts (SMEs). Escalates training related initiatives for Operational Excellence (OE). Participates in and/or contributes to advanced business process workflow activities. Actively engages in learning and development methodologies offerings (webinars, conferences, authoring tools, on demand learning).

Requirements

• Bachelor’s in Life Science or L&D and 3+ years of experience in cGMP environment OR High School Diploma or Equivalent with 5-7 years of experience in cGMP manufacturing environment.
• Knowledge of aseptic techniques and skills, contamination control, testing methods, and cleanroom behavior.
• Knowledge of biopharma laboratory and/or manufacturing experience.
• Knowledge of cGMP and GDP.
• Able to pass aseptic gowning qualification.
• Computer software skills including Microsoft Office.
• Self-motivated and able to work efficiently with minimal supervision.
• Excellent communication skills.
• Ability to work in a diverse, multi-cultural environment.
• Detail oriented.
• Willingness to “roll up sleeves” and do the work required for success.
• Must have the ability to work in a team-oriented environment and with clients.
• Must be able to work during the weekend, holidays and as required by the company.
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.
• Must be able to handle the standard/moderate noise of the manufacturing facility.
• The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).
• Gowning proficiency as needed.
• An individual may occasionally exert up to 30 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects.
• Sedentary entails sitting most of the time but may involve walking or standing for brief periods.
• Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.
• Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
• Must have the ability to communicate information and ideas so others will understand.
• Must be able to exchange accurate information in person, and on the telephone.

Nice To Haves

• 1+ years of experience in a training role preferred (particularly On-The-Job Training).
• Experience using authoring and Learning development tools, i.e., Articulate Storyline, Adobe Captivate, Adobe Connect, PhotoShop, Lectora, Camtasia, Adobe Illustrator, Adobe After Effects, and/or Adobe Premiere.

Responsibilities

• Facilitate and conduct on-the-job training for new hires and existing personnel.
• Evaluate job proficiency and skills, providing coaching and feedback.
• Monitor personnel technique and application of learning.
• Facilitate resolution of corrective and preventative actions related to training.
• Create and revise Unit Operation Training for Onboarding Skillsets.
• Create and revise Client Specific training content.
• Escalate training related initiatives for Operational Excellence (OE).
• Participate in advanced business process workflow activities.
• Engage in learning and development methodologies.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree