Global Aseptic Training Lead

Role Summary

The Global Aseptic Training Lead is responsible for generating, updating, implementing, and delivering aseptic training programs across the AbbVie network. They ensure compliance with external and internal AbbVie policies and procedures affecting the aseptic program. The role includes delivering Aseptic Introduction training at regional training centers, providing semi-annual refresher training at internal AbbVie manufacturing sites, and chairing the Annual Aseptic Training event. Additional training such as Aseptic investigations, Aseptic Auditing, and Aseptic Leadership training will be delivered as needed. The role reports to the Director of Aseptic Manufacturing. The training lead also mentors site aseptic trainers and works with sites to develop targeted trainings; they lead continuous improvement projects to enhance training delivery and effectiveness and explore new technologies to improve the training experience.

Responsibilities

• Generate, modify, deliver and implement aseptic training for the AbbVie network (aseptic introduction, basic microbiology, aseptic investigation, auditing, aseptic leadership, etc.).
• Partner with appropriate Trainers and SMEs to ensure site training is effective and provided at a level to ensure understanding and effectiveness.
• Evaluate aseptic training for enhancing, streamlining, or consolidating to maximize training effectiveness, contact time, and maintaining aseptic best practices.
• Ensure alignment of training program with site teams through chairing aseptic training forum and active participation on other aseptic global forums.
• Work with sites and global SMEs to update and improve Aseptic best practices within the network.
• Mentor site aseptic trainers and SMEs.
• Generate and conduct Aseptic global training events to supplement routine training.
• Key Stakeholders: Manufacturing Operations; Quality Operations; Site Aseptic Trainer; Network Aseptic Manufacturing Director.

Qualifications

• Bachelor’s degree in Business Administration, Education, Engineering or Science based field required or equivalent relevant working experience.
• Knowledge of regulations and standards for Aseptic manufacturing and application to training.
• Demonstrated ability to mentor and influence outside of direct reporting relationships.
• Proven ability to generate training materials for an audience with diverse educational and experience background.
• At least 10 years of Operations/Quality/Training, combined experience is required.
• Strong organizational skills and the ability to work in a team environment.
• Excellent presentation skills required. Proven ability to lead and conduct critical training classes.
• Essential experience will include knowledge of GMP and training process.
• Ability to problem solve, initiate, and manage projects.