Process Expert – Manufacturing Quality & Investigations

Novartis AG; Indianapolis (IN); On-site; USD 85,000 - 159,000; Full time

Job summary

Novartis AG in Indianapolis, Indiana is seeking a Process Expert to provide frontline support to manufacturing teams, resolving product and process issues, driving root-cause investigations, and ensuring compliance with quality requirements. You will author and review manufacturing documentation, support process validations, and collaborate with production to ensure safe, efficient operations.

This role follows a 4x10 schedule (Mon-Thu, 10 hours) with potential adjustments based on business

Qualifications

• Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or relevant experience.
• Minimum of 3 years of experience in a process support, shop-floor role within cGMP manufacturing and/or Quality Assurance, and/or Quality Control.
• Demonstrated understanding of pharmaceutical processes, Good Manufacturing Practice requirements, and applicable regulatory considerations.
• Strong awareness of quality issues and the ability to support quality-focused manufacturing operations.
• Excellent technical writing skills, including experience supporting manufacturing documentation.
• Knowledge of root cause analysis, corrective and preventive actions, change control, and Good Documentation Practice.

Responsibilities

• Manage and maintain manufacturing documentation, including Master Batch Records, applicable SOPs, risk assessments, protocols, and other required documentation.
• Write and review technical documentation supporting manufacturing operations, including SOPs, batch records, and white papers.
• Collect data for ongoing process verification (OPV), evaluate product performance, and support implementation of corrective and preventive actions.
• Author, own, and ensure completion of investigations involving material transfer, API synthesis, formulation, filling, inspection, and packaging.
• Ensure manufacturing processes are always inspection-ready and support process optimization and new technology introduction.
• Review validation protocols and reports and support execution of process validations and short-term improvement projects.
• Provide guidance and support to production teams through training, knowledge sharing, and leadership to drive processes through completion

Skills

Data Analytics

Education

Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry

Job description

Novartis AG in Indianapolis, Indiana is seeking a Process Expert to provide frontline support to manufacturing teams, resolving product and process issues, driving root-cause investigations, and ensuring compliance with quality requirements. You will author and review manufacturing documentation, support process validations, and collaborate with production to ensure safe, efficient operations.

This role follows a 4x10 schedule (Mon-Thu, 10 hours) with potential adjustments based on business