Night-Shift Process Engineer - Validation & Optimization

Merck & Co.

Piscataway Township (NJ)

On-site

USD 65,000 - 80,000

Full time

12 days ago

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Job summary

Amneal is seeking an Associate Process Engineer to support plant operations, implement improvements, validation, and SOP development. The role involves writing SOPs, developing process flow, reviewing procurement documents, and aiding in equipment validation. Night shift operates 12-hour days on a rotating schedule.

Requires a BA/BS in engineering or pharmaceutics and 1+ year of related experience. The position emphasizes process simulations, data-driven decisions, and collaboration with

Qualifications

BS degree in Engineering/Pharmaceutics or related field required.
Master's degree preferred.
1 year or more in Engineering/Pharmaceutics/Industrial Pharmacy.

Responsibilities

Support process/validation engineer to implement improvements and validation.
Perform process simulations and optimization studies.
Monitor process performance and identify improvement opportunities.
Assist in SOPs, equipment installation, and validation protocols.
Support CAPA and RCA investigations.
Ensure compliance with FDA/cGMP and quality standards.

Skills

Process engineering

Validation engineering

SOP writing

Data analysis

Continuous improvement

CAPA implementation

Vendor communication

Education

Bachelor's degree in Engineering/Pharmaceutics/Industrial Pharmacy

Master's degree in Engineering/Pharmaceutics/Industrial Pharmacy

Tools

Statistical analysis tools

Process simulation software

Regulatory/compliance tools

Job description

Requires a BA/BS in engineering or pharmaceutics and 1+ year of related experience. The position emphasizes process simulations, data-driven decisions, and collaboration with

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