Aseptic and Qualification Project Specialist

Novartis•Indianapolis, IN

3d•Onsite

About The Position

Based in Indianapolis, Indiana, 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, while supporting qualification and technology transfer initiatives. Through classroom and aseptic production training, the specialist strengthens technical capabilities and promotes continuous learning and growth. The position requires 5–10% travel. Novartis is unable to provide relocation support for this role. The posted salary range is $98,700–$183,300 per year; the description also lists a salary range of $81,200–$150,800. Final compensation depends on factors including relevant skills and experience and may be reviewed periodically. Compensation includes a performance-based cash incentive and, depending on role level, possible eligibility for annual equity awards. Eligible U.S.-based employees receive health, life, and disability benefits; a 401(k) with company contribution and match; and other benefits. Time off includes vacation, personal days, holidays, and other leaves.

Requirements

Bachelor's degree in education, science, or a related field, or equivalent relevant experience.
At least 4 years of relevant experience in aseptic pharmaceutical manufacturing.
Knowledge and understanding of cGMP requirements and application of continuous improvement in a regulated environment.
Strong leadership, communication, analytical, and problem-solving skills.
Demonstrated experience collaborating across functions and sites.
Ability to travel 5–10%.

Nice To Haves

Prior experience or training in radiochemistry or radiopharmacy.

Responsibilities

Develop and implement technical training programs and curricula aligned with employee learning needs.
Lead the 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 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.