Aseptic Training & Qualification Project Lead

U469 (FCRS = US469) AAA USA Inc.; Indianapolis (IN); On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis in Indianapolis, IN is seeking an Aseptic and Qualification Project Specialist to lead and coordinate technical training initiatives across Operations, with a focus on production qualification projects.

You will partner with subject matter experts to develop training programs, materials, procedures, protocols and records while supporting qualification and technology transfer initiatives, through classroom and aseptic production training.

Qualifications

• Bachelor's degree in education, science, a related field, or equivalent relevant experience.
• Minimum of 4 years of relevant experience in aseptic pharmaceutical manufacturing.
• Knowledge and understanding of cGMP requirements and the application of continuous improvement within a regulated environment.

Responsibilities

• Develop and implement comprehensive technical training programs and curricula aligned with employee learning needs.
• Lead planning, execution, and completion of activities supporting production operator qualifications.
• Serve as the primary liaison between project teams and production operations for qualification and technology transfer initiatives.
• Design and deliver engaging training materials, presentations, and hands-on learning in classroom and aseptic production environments.
• Collaborate with subject matter experts and stakeholders to align training requirements and content with business objectives.
• Evaluate training effectiveness, track trainee progress, and continuously improve materials and methodologies using shop-floor best practices.
• Maintain training documentation and provide progress updates on the effectiveness and impact of technical training initiatives.

Skills

Data Analytics

Digital Literacy

HSE Policy

Education

Bachelor's degree in education/science/related field

Job description

Novartis in Indianapolis, IN is seeking an Aseptic and Qualification Project Specialist to lead and coordinate technical training initiatives across Operations, with a focus on production qualification projects.

You will partner with subject matter experts to develop training programs, materials, procedures, protocols and records while supporting qualification and technology transfer initiatives, through classroom and aseptic production training.