Night-Shift Process Engineer - Automation & QA

Amneal Pharmaceuticals LLC

Piscataway Township (NJ)

On-site

USD 65,000 - 80,000

Full time

12 days ago

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Job summary

Amneal Pharmaceuticals LLC in Piscataway, NJ, is seeking an Associate Process Engineer for the night shift to support operation managers and engineers in validating and improving manufacturing processes, developing SOPs, and validating equipment.

You will analyze data, run process simulations, assist with validations, and ensure compliance with FDA regulations and cGMP, while collaborating across teams on continuous improvement.

Qualifications

Bachelor's degree in Engineering, Pharmaceutics, Industrial Pharmacy or related field required.
1 year or more in Engineering, Pharmaceutics, Industrial Pharmacy.
Master's degree preferred.
Knowledge of cGMP and FDA regulations is desirable.

Responsibilities

Support process/validation engineer to implement improvements and perform validations.
Conduct process simulations and optimization studies; support equipment installations.
Monitor process performance and identify improvement opportunities.
Assist in SOP development and change controls; analyze deviations and perform RCA.
Generate reports and drive data-based decision making.

Skills

Automation

Lean Manufacturing

Product Quality (QA/QC)

Quality Management Systems

Statistical Process Controls

Other skills

Education

Bachelor's degree in Engineering, Pharmaceutics, Industrial Pharmacy or related field

Master's degree in Engineering, Pharmaceutics, Industrial Pharmacy or related field

Tools

AutoCAD

Job description

You will analyze data, run process simulations, assist with validations, and ensure compliance with FDA regulations and cGMP, while collaborating across teams on continuous improvement.

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