Aseptic and Qualification Project Specialist

Novartis Group Companies; Indianapolis (IN); Vor Ort; USD 81.000 - 151.000; Vollzeit

Zusammenfassung

Novartis Group of Companies in Indianapolis, Indiana, is seeking an Aseptic and Qualification Project Specialist to lead and coordinate technical training across Operations, focusing on production qualification projects and technology transfer. You will develop training programs, materials, procedures, and records while collaborating with SMEs to ensure alignment with business objectives.

The role requires a Bachelor's degree or equivalent, 4+ years in aseptic pharma manufacturing, and a 5-10%

Qualifikationen

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

Aufgaben

• Develop and implement technical training programs and curricula.
• Lead planning, execution, and completion of operator qualification activities.
• Act as liaison between project teams and production operations for qualification and tech transfer.
• Design and deliver training materials, presentations, and hands-on learning in aseptic environments.
• Collaborate with SMEs to align training with business objectives.
• Evaluate training effectiveness and track progress to improve materials and methods.
• Maintain training documentation and provide progress updates.

Kenntnisse

Data Analytics

Digital Literacy

HSE Policy

Ausbildung

Bachelor's degree or equivalent

Jobbeschreibung

Job Description Summary

Location: Indianapolis, Indiana

Relocation Support: This role is based in Indianapolis, Indiana. Novartis is unable to offer relocation support: please only apply if accessible.

Job Description

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.

#LI-Onsite

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.

The salary for this position is expected to range between $98,700 and $183,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Salary Range: $81,200.00 - $150,800.00

Skills Desired

• Data Analytics
• Digital Literacy
• Health, Safety, and Environment (HSE) Policy

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.