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 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.
• Site point of contact for planning, orchestrating, executing, and closing activities linked to production operator qualifications.
• Serve as primary liaison between the project team and production operations to ensure successful qualification/tech transfer initiatives integrated into the training program.
• Assist in defining agendas, delivering content, and preparing for governance meetings for assigned projects.
• Establish project change management and manage changes across a multifunctional organization.
• Design 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 SMEs and stakeholders to identify training requirements and align content with business objectives.
• Evaluate training effectiveness through feedback, surveys, and performance metrics.
• Update and improve training materials and methodologies based on shop floor best practices and industry trends.
• Monitor trainee progress and provide additional support as needed.
• Maintain training documentation including manuals, guides, training records, and online resources.
• Act as a mentor and coach to employees for technical development and career growth.
• Liaise with other departments to address cross-functional training needs.
• Collaborate with external training providers as needed for specialized programs.
• Stay abreast of technology and industry standards to update training content.
• Champion a culture of continuous learning and professional development.
• Provide regular progress reports to management on training effectiveness and impact.

Qualifications

• Bachelor‚Äôs degree in education, science, or related field or equivalent experience
• 4 years of relevant experience in aseptic pharmaceutical manufacturing
• Direct experience in a cGMP and aseptic environment preferred
• Prior experience or training in radiochemistry or radiopharmacy desired
• Strong leadership, communication, and analytical/problem-solving skills
• Collaborative experience across functions and sites
• Knowledge of cGMP requirements and continuous improvement in a regulated environment
• 5-10% travel

Skills

• Technical training development
• Training program management
• Stakeholder engagement
• Change management
• Curriculum design and materials development
• Assessment and metrics

Education

• Bachelor‚Äôs degree in education, science, or related field or equivalent experience

Additional Requirements

• Travel up to 5-10% as needed