Night Shift Process Engineer - Validation & Optimization

RXinsider LTD.; Piscataway Township (NJ); Hybrid; USD 65,000 - 80,000; Full time

Benefits offered by this job

Health benefits

401(k) matching

Job summary

Amneal is seeking an Associate Process Engineer to support plant operations, validate improvements, and assist in SOPs and equipment validation. The role involves process simulations, data-driven optimization, and collaboration with cross-functional teams to drive quality and efficiency.

Responsibilities include monitoring process performance, performing RCA/CAPA, and ensuring adherence to FDA regulations. The position requires a Bachelor's in engineering or related field, with a Master’s

Qualifications

• Bachelor's degree in Engineering, Pharmaceutics, Industrial Pharmacy or related field (Required).
• Master's degree in Engineering, Pharmaceutics, Industrial Pharmacy preferred.
• 1+ year in Engineering, Pharmaceutics, Industrial Pharmacy

Responsibilities

• Support process/validation efforts for plant operations and new manufacturing processes.
• Perform process simulations and optimization studies; implement modifications and installations at manufacturing level.
• Assist in SOPs and equipment installation, op qualifications, validation protocols and change controls.
• Analyze manufacturing data using statistical methods to drive improvements.
• Investigate deviations; perform RCA and support CAPA implementation.
• Ensure compliance with FDA regulations and cGMP; support cross-functional teams on regulatory readiness.

Skills

Process engineering

SOP writing

Data analysis

RCA

CAPA

FDA cGMP

Education

Bachelor's degree in Engineering or related field

Master's degree preferred

Job description

Amneal is seeking an Associate Process Engineer to support plant operations, validate improvements, and assist in SOPs and equipment validation. The role involves process simulations, data-driven optimization, and collaboration with cross-functional teams to drive quality and efficiency.

Responsibilities include monitoring process performance, performing RCA/CAPA, and ensuring adherence to FDA regulations. The position requires a Bachelor's in engineering or related field, with a Master’s