Process Expert M-Th 12pm-10pm

Novartis • Indianapolis, IN

7d • Onsite

About The Position

Novartis is hiring a Process Expert based in Indianapolis, Indiana. This role provides frontline support to manufacturing teams and serves as a subject matter expert for product and process knowledge. The Process Expert helps resolve product and process issues, lead investigations to root cause, support corrective and preventive actions, and partner with production teams to ensure batches are manufactured safely and in compliance with established instructions and quality requirements.

The position follows a Monday-through-Thursday schedule of four 10-hour days, with adjustments possible based on business needs. The role is onsite in Indianapolis, and relocation support is not available.

Requirements

• Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or relevant experience in lieu of a degree.
• At least 3 years of experience in a process-support or shop-floor role within cGMP manufacturing, 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 introduction of new technology.
• Review validation protocols and reports and support process validation execution and short-term improvement projects.
• Guide and support production teams through training, knowledge sharing, and leadership to drive processes through completion.

Benefits

• Performance-based cash incentive.
• Depending on role level, eligibility to be considered for annual equity awards.
• Health benefits.
• Life benefits.
• 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