Process Expert M-Th 12pm-10am

U469 (FCRS = US469) AAA USA Inc.; Indianapolis (IN); On-site; USD 85,000 - 159,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Generous leave package

Job summary

Novartis in Indianapolis, Indiana seeks a Process Expert to support manufacturing teams. You will resolve process issues, drive root-cause investigations, and ensure compliance with GMP and quality requirements.

The role involves writing and reviewing manufacturing docs, leading investigations, and guiding training to drive processes forward. 4x10 work schedule onsite with competitive benefits.

Qualifications

• Bachelor's degree or relevant experience in lieu of a degree.
• Minimum 3 years in a process support, shop-floor role within cGMP manufacturing and/or QA/QC.
• Understanding of pharmaceutical processes, GMP requirements, and regulatory considerations.
• Strong quality focus and ability to support quality-focused manufacturing.
• Excellent technical writing skills for manufacturing documentation.
• Knowledge of root cause analysis, CAPA, change control, and GDP.

Responsibilities

• Manage and maintain manufacturing documentation including Master Batch Records and SOPs.
• Write and review documentation supporting manufacturing operations (SOPs, batch records, white papers).
• Collect data for OPV, evaluate product performance, and support CAPA actions.
• Author and complete investigations involving material transfer, API synthesis, formulation, filling, inspection, packaging.
• Ensure processes are inspection-ready and support optimization and new tech introduction.
• Review validation protocols/reports and support process validations and short-term improvements.
• Provide training and leadership support to production teams to drive processes to completion.

Skills

Process knowledge

Technical writing

Root cause analysis

Quality assurance

cGMP awareness

Process improvement

Education

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

Job description

Job Description Summary

Location: Indianapolis, Indiana Relocation Support: This role is based in Indianapolis, Indiana. Novartis is unable to offer relocation support: please only apply if accessible.

Make a direct impact on manufacturing excellence and help ensure critical therapies are produced safely and to the highest quality standards.

As a Process Expert, you will provide frontline support to manufacturing teams, serving as a subject matter expert for product and process knowledge. You will help resolve product and process issues, drive investigations to true root cause, support corrective and preventive actions, and partner with production teams to ensure each batch is manufactured safely and in compliance with established instructions and quality requirements.

NOTE: This role will work a 4x10 schedule - Monday through Thursday, 10 hours each day. Adjustments may be necessary based on business need. #LI-Onsite

Job Description Key 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.

Essential 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, 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.

Desirable Requirements

• Previous radiopharmaceutical experience.

The salary for this position is expected to range between $85,400 and $158,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range $85,400.00 - $158,600.00

Skills Desired

Data Analytics Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people's lives.