Aseptic and Qualification Project Specialist

Novartis AG•Indianapolis, IN

36d

About The Position

The Aseptic and Qualification Project Lead is accountable for leading and coordinating all technical training initiatives across the operations organization with a key specialized focus on production qualification projects. As a vital member of the team, the Lead will oversee the development and implementation of training programs, facilitate the creation of high-quality training materials, procedures, protocols, records, actively support the training plan by engaging with various stakeholders within a classroom for aseptic training environments and new technologies. With a focus on optimizing employee skillsets and knowledge, Aseptic and Qualification Project Lead will play a crucial role in elevating the organization's technical capabilities and fostering a culture of continuous learning and growth.

Requirements

Bachelor's degree in education, science or related field or equivalent experience
4 years' relevant experience required with aseptic pharmaceutical manufacturing
Direct experience working in a cGMP and aseptic environment is highly desired.
Strong leadership, communication and analytical/problem solving skills
Demonstrated history of working collaboratively across functions and sites.
Knowledge and understanding of cGMP requirements and the application of continuous improvement in a regulated environment.
5-10% travel

Nice To Haves

Prior experience or training in radiochemistry or radio pharmacy desired

Responsibilities

Develop and implement comprehensive technical training programs and curricula to address the learning needs of employees.
Site point of contact for planning, orchestrating, executing, and closing all activities linked to production operator qualifications
Primary liaison between the project team and production operations to ensure all qualification/tech transfer initiatives are successful implemented by seamlessly integrating the training and process learning into the existing training program and applicable personnel
Support in defining and planning agendas, delivering content and lead preparation for key site management engagements and governance meetings for assigned projects
Establish Project Change Management & manage changes successfully throughout a complex multifunctional organization
Manage and design engaging and effective training materials, presentations, and hands-on activities to facilitate learning in a classroom and more importantly aseptic production environment.
Coordinate and conduct technical training sessions for employees at all levels.
Collaborate with subject matter experts and stakeholders to identify training requirements and ensure training content aligns with business objectives.
Evaluate and assess the effectiveness of training programs through feedback, surveys, and performance metrics.
Continuously update and improve training materials and methodologies-based shop floor best practices and industry trends.
Monitor and track the progress of trainees, providing additional support or resources as needed to ensure successful outcomes.
Establish and maintain training documentation, including manuals, guides, operator training records and online resources for easy access and reference.
Act as a mentor and coach to employees, assisting them in their technical development and career growth.
Liaise with other departments and teams to address cross-functional training needs and ensure a cohesive learning experience.
Collaborate with external training providers, if necessary, to source specialized technical training programs.
Stay abreast of advancements in technology and industry standards to incorporate relevant updates into training content.
Champion a culture of continuous learning and professional development throughout the organization.
Provide regular progress reports and updates to management and stakeholders on the effectiveness and impact of technical training initiatives development.