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

U469 (FCRS = US469) AAA USA Inc.; Millburn (NJ); On-site; USD 70,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off

Job summary

Novartis in Millburn, NJ seeks an Associate Process Expert to support on‑the‑floor manufacturing and quality teams, resolving events and ensuring GMP compliance. The role leads investigations, CAPAs, and continuous improvement for Radioligand Therapy production on the 2nd shift (1:00 pm–11:00 pm, Wed–Sat).

The candidate will have a BS in Engineering/Pharmacy/Chemistry and at least 1 year on the shopfloor/QA/QC, with strong technical writing and cross‑functional collaboration skills.

Qualifications

• BS degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific discipline.
• Minimum one year of shopfloor and/or Quality Assurance/Quality Control experience in a GMP facility.
• Understanding of pharmaceutical manufacturing processes and regulatory requirements.
• Strong technical writing skills for clear, inspection-ready documentation.

Responsibilities

• Provide on-the-floor support by triaging manufacturing events with Production and Quality teams.
• Open, author, and drive deviations and investigations to timely closure.
• Apply process knowledge and root cause analysis to resolve issues.
• Develop and implement corrective and preventive actions to prevent recurrence.
• Ensure investigations are complete, accurate, and inspection-ready for critical events.
• Execute or support experiments and manufacturing runs to support investigations.
• Partner cross-functionally to maintain compliant operations during and after deviations.

Skills

Cross-functional collaboration

Technical writing

Quality mindset

Problem solving

Education

BS in Engineering/Pharmacy/Chemistry

Job description

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. #LI-Onsite

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.

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.

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 [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.

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

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