2nd Shift GMP Process Investigator & CAPA

BioNJ Inc.; Millburn (NJ); On-site; USD 70,000 - 130,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company contribution and,

Generous time off including vacation &

Job summary

Novartis in Millburn, NJ seeks an Associate Process Expert to support manufacturing and quality teams on the shopfloor. You will lead investigations, drive CAPAs, and strengthen a culture of continuous improvement in a GMP environment.

This 2nd shift role (1:00 pm–11:00 pm, Wed–Sat) focuses on safe, reliable production of Radioligand Therapy treatments, ensuring deviations are resolved and processes remain inspection-ready.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or equivalent.
• Minimum one year on shopfloor or QA/QC in a GMP manufacturing facility.
• Solid understanding of pharma manufacturing processes and regs.
• Strong technical writing for inspection-ready documentation.
• Demonstrated ability to work cross‑functionally with quality and production.

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 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 and inspection-ready for major events.
• Execute or support experiments and manufacturing runs for investigations.
• Partner cross-functionally to maintain compliant operations during deviations.

Skills

Forklift Operations

GMP Compliance

HSE Policy

Inventory Management

Machine Operations

Manufacturing

Operations Management

Process Improvements

Production Management

Quality Control

Regulatory Documents

Education

B.S. in Engineering, Pharmacy, or Chemistry

Job description

Novartis in Millburn, NJ seeks an Associate Process Expert to support manufacturing and quality teams on the shopfloor. You will lead investigations, drive CAPAs, and strengthen a culture of continuous improvement in a GMP environment.

This 2nd shift role (1:00 pm–11:00 pm, Wed–Sat) focuses on safe, reliable production of Radioligand Therapy treatments, ensuring deviations are resolved and processes remain inspection-ready.