Manufacturing Specialist; weekend day shift

Position Overview

Novartis is seeking a Manufacturing Specialist (weekend day shift) to provide frontline support to manufacturing operations. In this role you will work with production teams to ensure that every batch is manufactured safely and in compliance with batch instructions and quality requirements. You will serve as a Subject Matter Expert (SME) for product and process knowledge, driving investigations to identify true root causes and implementing corrective and preventive actions. This full‑time position is based in Indianapolis, IN. Please note, there is no relocation support for this role.

Shift: Weekend Days (mandatory overtime may be required).

Key Responsibilities

• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other necessary documents.
• Provide technical writing and review support for manufacturing operations, including SOPs, batch records, and white papers.
• Collect data for ongoing process verification (OPV), track product performance, and support the implementation of CAPAs.
• Lead and own investigations related to material transfer, isotope manufacturing, and packaging.
• Ensure processes remain inspection‑ready at all times.
• Support process optimization, new technology introduction, and productivity improvement initiatives.
• Review validation protocols and reports; support process validations and short‑term improvement projects.
• Provide guidance and training to the production team and share product/process knowledge.
• Demonstrate leadership by driving processes to closure while adhering to established guidelines and procedures.
• Participate in qualification/validation activities as necessary.
• Foster a culture of “speaking up” to ensure all cGMP compliance activities are followed.
• Prepare essential documents and records such as batch records, shipping documents, and training materials.
• Participate in periodic mandatory overtime to maintain process continuity.
• Ensure overall inspection readiness, including timely reporting of technical complaints, adverse events, or special case scenarios.

Required Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or relevant experience in lieu of degree.
• 3+ years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
• Strong awareness of quality issues with demonstrated compliance investigations experience.
• Good understanding of manufacturing and validation requirements and activities.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Proficient in MS Office applications.

Preferred Qualifications

• Training in radiochemistry or radiopharmacy is preferred.

Benefits & Perks

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