Manufacturing Specialist; weekend night shift

Join to apply for the Manufacturing Specialist (weekend night shift) role at Novartis

Location:

Indianapolis, IN. Novartis is unable to offer relocation support for this role. Please only apply if you can be located onsite.

Shift: Weekend Nights – position may involve mandatory overtime as needed.

You will provide front‑line support to manufacturing, working closely with production teams to ensure each batch is manufactured safely and in compliance with batch instructions and quality requirements. As a Subject‑Matter Expert, you will be the first point of contact for product and process issues, drive root‑cause investigations, and implement corrective and preventive actions.

• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation.
• Technical writing and reviewing to support manufacturing operations (SOPs, batch records, white papers).
• Collect data for ongoing process verification (OPV) and support tracking and evaluation of product performance and implementation of CAPAs.
• Own investigations related to material transfer, isotope manufacturing, and packaging.
• Ensure processes remain inspection‑ready at all times.
• Support process optimisation and new technology introduction for continued productivity improvement.
• Review validation protocols and reports; support execution of process validations and short‑term improvement projects.
• Provide guidance and support to the production team through training and knowledge sharing.
• Demonstrate leadership and guide processes to closure/completion while following all required guidelines and procedures.
• Participate in assigned qualification/validation activities as necessary.
• Facilitate a culture of “speaking up” and ensure all cGMP compliance activities are followed.
• Prepare applicable documents and records such as batch records, shipping documents, and training materials.
• Participate in periodic mandatory overtime to ensure process continuity and completion.
• Other duties may be assigned as necessary.
• Ensure overall inspection readiness for area of responsibility and report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.

• Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of a degree.
• Training in radiochemistry or radiopharmacy is preferred.
• 3+ years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
• Strong awareness of quality issues and compliance‑investigation experience.
• Good understanding of manufacturing and validation requirements and activities.
• Ability to exploit new technology and techniques to eliminate non‑value‑adding activities and improve productivity/performance.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Proficient in MS Office applications.

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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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.

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If 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 [email protected] or call  and let us know the nature of your request and your contact information.

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Mid‑Senior level

Full‑time

Management and Manufacturing

Pharmaceutical Manufacturing