Process Expert M-Th 12pm-10pm

Novartis AG; Indianapolis (IN); Vor Ort; USD 85.000 - 159.000; Vollzeit

Zusammenfassung

Novartis AG in Indianapolis, Indiana is seeking a Process Expert to provide frontline support to manufacturing teams, resolving product and process issues, driving root-cause investigations, and ensuring compliance with quality requirements. You will author and review manufacturing documentation, support process validations, and collaborate with production to ensure safe, efficient operations.

This role follows a 4x10 schedule (Mon-Thu, 10 hours) with potential adjustments based on business

Qualifikationen

• Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or relevant experience.
• 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.

Aufgaben

• 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

Kenntnisse

Data Analytics

Ausbildung

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

Jobbeschreibung

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 is role will work a 4x10 schedule - Monday through Thursday, 10 hours each day. Adjustments may be necessary based on business need.

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.

Salary Range

$85,400.00 - $158,600.00

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.

Skills Desired

Data Analytics

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 to perform the essential functions of a position, 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.

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.