Process Expert M-Th 12pm-10am
Novartis
Summary
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. This is a shift-based role.
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.
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
- Previous radiopharmaceutical experience (desirable)
Benefits
- Health Insurance
- Life Insurance
- Disability Benefits
- 401(k) Matching
- Performance-Based Cash Incentive
- Annual Equity Awards
- Vacation
- Personal Days
- Holidays
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.