Associate Process Expert (Wed-Sat/2nd shift)

Job Description Summary

Location: Millburn, NJ, United States

Relocation Support: This role is based in Millburn, NJ, United States. Novartis is unable to offer relocation support: please only apply if accessible.

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.

NOTE: This is a 2nd shift role, hours are expected to be 1:00 pm - 11:00 pm, Wednesday - Saturday.

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Job Description

Key Responsibilities

• Provide onthefloor 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 inspectionready for critical and major events.
• Execute or support experimental plans and manufacturing runs required to support investigations.
• Partner crossfunctionally 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 inspectionready documentation.
• Demonstrated quality mindset with the ability to work effectively on the shopfloor with crossfunctional teams.

Desirable Requirements

• Handson experience authoring and managing deviations, investigations, and corrective and preventive actions.
• Radioligand therapy manufacturing experience.

The salary for this position is expected to range between $33.65 and $62.60 per hour. 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.

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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, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$70,000.00 - $130,000.00

Skills Desired

Forklift Operations, GMP Compliance, Health, Safety, and Environment (HSE) Policy, Inventory Management, Machine Operations, Manufacturing, Operations Management, Process Improvements, Production Management, Quality Control (QC), Regulatory Documents