Technical Trainer - Cell Gene Therapy Manufacturing

Position Summary

Serves as primary technical trainer in order to facilitate and conduct on-the-job technical training for new hires and ongoing improvement and proficiency 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.
• Creation and revision of Unit Operation Training for Onboarding Skillsets consisting of but not limited to User Manuals, Instructor Manuals, Instructor-Led Trainings, On-the-Job trainings, Videos and Final Assessments in collaboration with site partners.
• Creation and revision of Client Specific training content consisting of but not limited to User Manuals, Instructor Manuals, Instructor-Led Trainings, 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).

• Organized and capable of successfully managing multiple priorities using effective time management techniques.
• Ability to present and communicate effectively.
• Must be accountable for work product and demonstrate strong work ethic.

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

• Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Attend all required Quality & Compliance training at the specified interval.

• Gowning Qualification
• Aseptic Techniques

• Technical Trainers supporting cleanroom activities must be able to comply with Minaris personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role.

• 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.
• This…