Process Expert M-Th 12pm-10am

Novartis • Indianapolis, IN

8d • $85,400 - $158,600 • Onsite

About The Position

The Process Expert provides frontline support to manufacturing teams and serves as a subject matter expert in product and process knowledge. The role helps resolve product and process issues, drives investigations to root cause, supports corrective and preventive actions, and partners with production teams to ensure batches are manufactured safely and in compliance with established instructions and quality requirements. This is a shift-based, onsite role in Indianapolis, Indiana. Novartis does not offer relocation support for this position.

Responsibilities include maintaining manufacturing documentation; preparing technical documents; collecting and evaluating ongoing process verification data; owning investigations across manufacturing stages; supporting inspection readiness, process optimization, technology introduction, validation activities, and improvement projects; and guiding production teams through training and knowledge sharing.

Requirements

• 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 or 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 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.

Nice To Haves

• Previous radiopharmaceutical experience.

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 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.

Benefits

• Performance-based cash incentive.
• Depending on the level of the role, eligibility to be considered for annual equity awards.
• Health, life, and disability benefits.
• 401(k) with company contribution and match.
• Vacation, personal days, holidays, and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level