Process Expert M-Th 12pm-10am
About The Position
The Process Expert provides frontline support to manufacturing teams as a subject matter expert in product and process knowledge. The role helps resolve product and process issues, investigate problems to determine root causes, 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. This is a shift-based, onsite role in Indianapolis, Indiana. Novartis does not offer relocation support for this position. The Process Expert maintains and authors manufacturing documentation, supports ongoing process verification and product performance evaluation, owns investigations, and helps keep processes inspection-ready. The role also supports process optimization, new technology introduction, validation activities, and short-term improvement projects, while guiding production teams through training, knowledge sharing, and leadership. The expected salary range is $85,400 to $158,600 per year. Compensation includes a performance-based cash incentive and, depending on role level, potential eligibility for annual equity awards. Eligible US-based employees receive health, life and disability benefits, a 401(k) with company contribution and match, and paid time off including vacation, personal days, holidays, and other leaves.
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 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.
- Data analytics skills.
Responsibilities
- Manage and maintain manufacturing documentation, including Master Batch Records, applicable SOPs, risk assessments, protocols, and other required documents.
- 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 remain inspection-ready and support process optimization and new technology introduction.
- Review validation protocols and reports, and support process validation execution and short-term improvement projects.
- Provide production teams with guidance and support through training, knowledge sharing, and leadership to drive processes through completion.
- Help resolve product and process issues and drive investigations to true root cause.
- Partner with production teams to ensure batches are manufactured safely and in compliance with established instructions and quality requirements.
Benefits
- Health benefits
- Life benefits
- Disability benefits
- 401(k) with company contribution and match
- Vacation
- Personal days
- Holidays
- Other leaves
- Performance-based cash incentive
- Potential eligibility for annual equity awards, depending on role level
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
