Pharma Process Excellence Specialist

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

Benefits offered by this job

Health, life & disability benefits

401(k) with company match

Comprehensive benefits package

Job summary

Novartis Group of Companies in Indianapolis, Indiana is seeking a Process Expert to provide frontline support to manufacturing teams, acting as a subject matter expert for product and process knowledge to ensure each batch is manufactured safely and in compliance with instructions and quality requirements.

You will investigate issues, drive root-cause analysis, support corrective and preventive actions, and partner with production teams to train and share knowledge to improve processes and

Qualifications

• Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or relevant experience in lieu of a degree.
• 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 or equivalent experience

Job description

Novartis Group of Companies in Indianapolis, Indiana is seeking a Process Expert to provide frontline support to manufacturing teams, acting as a subject matter expert for product and process knowledge to ensure each batch is manufactured safely and in compliance with instructions and quality requirements.

You will investigate issues, drive root-cause analysis, support corrective and preventive actions, and partner with production teams to train and share knowledge to improve processes and