Aseptic and Qualification Project Lead

Role Summary

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. The Lead will oversee the development and implementation of training programs, facilitate the creation of training materials, procedures, protocols, and records, and actively support the training plan by engaging with stakeholders in aseptic training environments and with new technologies. The role focuses on optimizing employee skillsets and knowledge to elevate technical capabilities and foster a culture of continuous learning.

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 successfully implemented by integrating training and process learning into the existing program and 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 and manage changes throughout a complex multifunctional organization
• Design and manage engaging training materials, presentations, and hands-on activities for classroom and aseptic production environments
• Coordinate and conduct technical training sessions for employees at all levels
• Collaborate with subject matter experts and stakeholders to identify training requirements and ensure 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 on shop floor best practices and industry trends
• Monitor and track trainee progress, providing additional support or resources as needed
• Establish and maintain training documentation, including manuals, guides, operator training records and online resources
• Act as a mentor and coach to employees, assisting them in their technical development and career growth
• Liaise with other departments to address cross-functional training needs and ensure a cohesive learning experience
• Collaborate with external training providers to source specialized technical training programs
• Stay abreast of advancements in technology and industry standards to incorporate updates into training content
• Champion a culture of continuous learning and professional development
• Provide regular progress reports and updates to management and stakeholders on the effectiveness and impact of training initiatives

Qualifications

• Bachelor’s degree in education, science or related field or equivalent experience
• 4 years’ relevant experience with aseptic pharmaceutical manufacturing
• Direct experience in a cGMP and aseptic environment is highly preferred
• Prior experience or training in radiochemistry or radiopharmacy 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 continuous improvement in a regulated environment
• 5-10% travel

Skills

• Technical training program design
• Project coordination and change management
• Stakeholder engagement and cross-functional collaboration
• Instructional design and effective training material development
• Learning assessment and metrics analysis
• Documentation management

Education

• Bachelor’s degree in education, science or related field or equivalent experience

Additional Requirements

• 5-10% travel