Aseptic and Qualification Project Specialist
About The Position
The Aseptic and Qualification Project Specialist leads and coordinates technical training initiatives across Operations, with a specialized focus on production qualification projects. The role partners with subject matter experts and stakeholders to develop training programs, materials, procedures, protocols, and records, and supports qualification and technology transfer initiatives. Through classroom and aseptic production training, the specialist helps strengthen technical capabilities and foster continuous learning and growth. The position is based onsite in Indianapolis, Indiana. Novartis is unable to offer relocation support. The role requires 5–10% travel.
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.
- Willingness to travel 5–10%.
Nice To Haves
- Prior experience or training in radiochemistry or radiopharmacy.
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 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.
Benefits
- Performance-based cash incentive.
- Depending on the level of the role, eligibility to be considered for annual equity awards.
- Health, life, and disability benefits.
- 401(k) with company contribution and match.
- Vacation, personal days, holidays, and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
