Process Engineer Associate: Validation, Optimization & SOPs

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Health benefits

401(k) matching

Bonus potential

Job summary

Amneal is seeking an Associate Process Engineer to support process improvements, validation, and automation across our Newark-area plant operations. This role will help develop and update SOPs, assist in equipment qualifications, and analyze manufacturing data to drive quality and efficiency.

The candidate will collaborate with cross-functional teams to sustain cGMP compliance and contribute to continuous improvement initiatives while supporting regulatory readiness and production uptime.

Qualifications

• Bachelor's degree in Engineering, Pharmaceutics, Industrial Pharmacy, or related field required.
• Master's degree in Engineering or related field preferred.
• 0–3 years experience in Engineering, Pharmaceutics, Industrial Pharmacy, or Pharmaceutical Manufacturing.

Responsibilities

• Support process/validation engineer and plant operations to implement improvements and perform validations.
• Monitor process performance and identify opportunities for yield, efficiency, quality, and reliability gains.
• Assist in SOP development and execution of equipment installation and qualification protocols.
• Analyze manufacturing data using statistical tools to drive data-based decisions.
• Investigate deviations, perform root cause analysis, and support CAPA implementation.

Skills

Process optimization

Data analysis

SOP writing

CAPA

Education

BA/BS in Engineering or related field

MS in Engineering or related field (preferred)

Job description

Amneal is seeking an Associate Process Engineer to support process improvements, validation, and automation across our Newark-area plant operations. This role will help develop and update SOPs, assist in equipment qualifications, and analyze manufacturing data to drive quality and efficiency.

The candidate will collaborate with cross-functional teams to sustain cGMP compliance and contribute to continuous improvement initiatives while supporting regulatory readiness and production uptime.