Process Expert M-Th 12pm-10pm

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

Job summary

Novartis is seeking a Process Expert in Indianapolis to support manufacturing teams as a subject matter expert for product and process knowledge. You will help resolve issues, drive investigations to root cause, and ensure batches are manufactured safely and in compliance.

This role follows a 4x10 schedule (Mon-Thu, 10 hours) with onsite work. You will write and review master batch records and SOPs, participate in validations, and train production staff to uphold quality and continuous

Qualifications

• Bachelor's degree in Engineering, Pharmacy, or a related field.
• Minimum 3 years in a process support, shop-floor role within cGMP manufacturing or QA/QC.
• Strong understanding of pharmaceutical processes and GMP requirements.
• Excellent technical writing skills with documentation experience.
• Knowledge of RCA, CAPA, change control, and GDP.

Responsibilities

• Manage and maintain manufacturing documentation (MBRs, SOPs, risk assessments, protocols).
• Write and review manufacturing documentation (SOPs, batch records, white papers).
• Collect data for OPV, evaluate product performance, support CAPA.
• Lead investigations involving material transfer, API synthesis, formulation, filling, inspection, packaging.
• Ensure processes are inspection-ready and support optimization and new technology introduction.
• Review validation protocols and support process validations and short-term improvement projects.
• Provide guidance and training to production teams to drive processes to completion.

Skills

Technical writing

Root cause analysis

GMP knowledge

Investigations

Education

Bachelor's degree in Engineering, Pharmacy or related field

Job description

Band Level 3 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 product 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 is role will work a 4x10 schedule - Monday through Thursday, 10 hours each day. Adjustments may be necessary based on business need. #LI-Onsite

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.

Salary Range $85,400.00 - $158,600.00

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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, or in order to perform the essential functions of a position, please send an e-mail to [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

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