Associate Process Expert (Wed-Sat/2nd shift)
Novartis
Summary
Are you motivated by solving complex manufacturing challenges where quality, compliance, and patients come first? As an Associate Process Expert, you will play a critical role on the shopfloor, acting as a trusted partner to manufacturing and quality teams to resolve unexpected events and ensure processes remain compliant, robust, and inspection ready. Your work will directly support safe, reliable production of our cutting-edge Radioligand Therapy (RLT) treatments by leading investigations, driving effective corrective and preventive actions, and strengthening a culture of continuous improvement in a fast-paced Good Manufacturing Practice (GMP) environment.
Job description
NOTE: This is a 2nd shift role, hours are expected to be 1:00 pm – 11:00 pm, Wednesday – Saturday.
Key Responsibilities
- Provide on-the-floor support by triaging unexpected manufacturing events with Production and Quality teams.
- Open, author, and drive deviations and investigations to timely, compliant closure.
- Apply process knowledge and root cause analysis tools to identify and resolve product or process issues.
- Develop, document, and implement effective corrective and preventive actions to prevent recurrence.
- Ensure investigations are complete, accurate, defensible, and inspection-ready for critical and major events.
- Execute or support experimental plans and manufacturing runs required to support investigations.
- Partner cross-functionally to maintain compliant manufacturing operations during and after deviations.
Essential Requirements
- Bachelor of Science degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific discipline.
- Minimum one year of experience on the shopfloor and/or Quality Assurance or Quality Control department(s) of a GMP manufacturing facility.
- Proven understanding of pharmaceutical manufacturing processes and regulatory requirements.
- Strong technical writing skills with the ability to produce clear, complete, and inspection-ready documentation.
- Demonstrated quality mindset with the ability to work effectively on the shopfloor with cross-functional teams.
Desirable Requirements
- Hands-on experience authoring and managing deviations, investigations, and corrective and preventive actions.
- Radioligand therapy manufacturing experience.
Requirements
- Bachelor of Science degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific discipline
- Minimum one year of experience on the shopfloor and/or Quality Assurance or Quality Control department(s) of a GMP manufacturing facility
- Proven understanding of pharmaceutical manufacturing processes and regulatory requirements
- Strong technical writing skills with the ability to produce clear, complete, and inspection-ready documentation
- Demonstrated quality mindset with the ability to work effectively on the shopfloor with cross-functional teams
- Hands-on experience authoring and managing deviations, investigations, and corrective and preventive actions
- Radioligand therapy manufacturing experience
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.