Aseptic and Qualification Project Specialist
Novartis
Summary
Help shape how teams build the skills and qualifications needed to succeed in aseptic manufacturing. As an Aseptic and Qualification Project Specialist, you will lead and coordinate technical training initiatives across Operations, with a specialized focus on production qualification projects. You will partner with subject matter experts and stakeholders to develop effective training programs, materials, procedures, protocols, and records while supporting qualification and technology transfer initiatives. Through classroom and aseptic production training, you will help strengthen technical capabilities and foster a culture of continuous learning and growth.
Job description
Key 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.
Essential Requirements
- 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.
- Strong leadership, communication, analytical, and problem-solving skills.
- Demonstrated experience working collaboratively across functions and sites.
- 5–10% travel
Desirable Requirements
- Prior experience or training in radiochemistry or radiopharmacy.
Requirements
- 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
- Strong leadership, communication, analytical, and problem-solving skills
- Demonstrated experience working collaboratively across functions and sites
- 5–10% travel
- Prior experience or training in radiochemistry or radiopharmacy (preferred)
Benefits
- Performance-Based Cash Incentive
- Annual Equity Awards
- Health Benefits
- Life Benefits
- Disability Benefits
- 401(k) Matching
- Vacation
- Personal Days
- Holidays
- Other Leaves
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.