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

Novartis•Millburn, NJ

8d•Onsite

About The Position

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.

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.

Nice To Haves

Hands‑on experience authoring and managing deviations, investigations, and corrective and preventive actions.
Radioligand therapy manufacturing experience.

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.