The Technical Training Specialist will report to the Sr. Manager of the Training Academy. Responsible for the administration of training in the CBM Training Academy. Provides technical support of GMP manufacturing operations. Works closely with department leadership to deliver a comprehensive “On the Job” training program that enables excellence in execution of manufacturing processes. Schedules new hire training module for Manufacturing and Testing and Analytics departments within CBM. The Technical Training Specialist is responsible for ensuring proper training and training compliance of the CBM staff to applicable SOPs, guidelines, and regulations within the Training Academy.
- Ensure all mandatory training requirements are executed as required
- Partner with Department Training Coordinators and Supervisors to map out training plans for individual groups
- Develop training aids such as visual aids, troubleshooting guides, manuals, and handbooks
- Assist with identifying, developing, and implementing future improvements
- Designs and applies assessment tools to measure training effectiveness
- Act as Subject Matter Expert (SME) for specific technical areas (e.g. aseptic gowning, aseptic processing using a BSC, viral vector manufacturing, flow cytometry)
- Schedules classroom or on-the-job training in a learning lab
- Responsible for effective delivery of training to client group. Includes classroom, one-on-one, and on-the-job training.
- Communicates training needs to local training management
- Responsible for effective delivery of cGMP and other regulatory training, as required
- Delivers initial and ongoing training for new hires and transfers.
- Coaches and develops SME/qualified trainers within each department to be effective trainers
- Collaborates with subject matter experts to support the development of OJT Task Evaluations and Instructor Led Courses.
- Facilitates transition of new hires/transfer-ins from training environment to work environment
- Identify internal and external training programs to address competency gaps, as needed
- Bachelor’s degree in a Science discipline, or equivalent experience
- Train the Trainer Certification desired but not required
- Prior hands-on experience with equipment and unit operations typically used in process development and manufacture of cell therapy products is preferred
- 4+ years in manufacturing operations in a GMP/BioPharma environment
- Training delivery experience required.
- History of maintaining personnel training and performance metrics.
- Strong knowledge of cGMP regulations and quality management systems.
- Working knowledge of MS Word, PowerPoint, Excel, and Outlook.
- Excellent written and verbal communication and interpersonal skills.
- Exhibits attention to detail, accuracy in work, and integrity of character.
- Possesses aptitude to learn and operate equipment and apply emerging learning technologies.
- Able to adhere to all safety and company regulations.
- Able to accommodate a flexible work schedule to support business demands.
- Ability to carry up to 55 pounds.
- Ability to stand for long periods of time while wearing various levels of PPE daily