Aseptic Manufacturing Training Lead

AbbVie•Waco, TX

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . The Aseptic Manufacturing Training Lead is responsible for designing, delivering, and implementing training programs for the assigned department members. The Aseptic Manufacturing Training Lead also has responsibility for maintaining employee training profiles in training system, filing training records, investigating late training events, and providing review of training related document updates. Ensures consistent compliance with external and internal AbbVie policies/procedures impacting the training program for the assigned department. Works with cross-functional team to assure consistent training practices throughout the operations. Leads continuous improvement projects to enhance training delivery and effectiveness and evaluate use of new technologies to enhance the training experience.

Requirements

Bachelor’s degree required. Degree program or professional certification in Education, Communication, Training, or a related field is beneficial.
Knowledge of regulations and standards for Aseptic manufacturing and application to training.
At least 3 years of Aseptic Operations/Quality/Training, combined experience is required.
Essential experience should include knowledge of GMPs, aseptic manufacturing, and training processes.
Knowledge of regulations and standards for pharmaceutical testing operations and application to training.
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.

Responsibilities

Ensure AbbVie Training Policy, process and procedures and regulatory training requirements are implemented at the site.
Train new and existing employees on appropriate cleanroom behavior and best practices including but not limited to activities such as equipment intervention and sampling.
Supports implementation of global Aseptic Best Practices related to aseptic processes and training
Identify areas of improvement with current aseptic processes at the site and manage continued improvement projects, as needed.
Observe employees aseptic gowning technique and provide coaching.
Gowning Training (initial and recertification)
Partner with Microbiology and Operations for Environmental Monitoring and Sanitization Training
Monthly shift touchpoints focused on a pre-established rolling Aseptic refresher (target 15-20 min 10 topics, conducted when semi-annual refresher training is not performed)
Monthly Gemba walks with Aseptic MQA / site leadership
20% of time dedicated to Aseptic Auditing
Work with global Aseptic Trainers to develop, then deliver targeted aseptic trainings based on site needs
This position will support the entire site for aseptic training.
It will be working with the global staff to identify and help roll out additional training if required.
Gemba walks and on the floor training reinforcement.
Work with department/area supervisors and SMEs to schedule training on more complex methods/techniques.
Maintain training profiles for all trainees and enter completed and verified training into the training system and file training records as needed.
Complete periodic review and updates of training related documents as needed.
May also need to provide hands-on training for basic to more complex skills/techniques.