Associate Process Engineer - Pharma Manufacturing & Validation

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

Benefits offered by this job

Bonus potential

Health benefits

401(k) matching

Job summary

Amneal Pharmaceuticals LLC is seeking an Associate Process Engineer to support the Operations and Engineering teams in implementing improvements, validation, and automation for manufacturing processes. The role includes SOP writing, process flow development, equipment validation, and collaboration across departments to ensure compliance and efficiency.

The candidate will assist in process optimization, monitor performance, and apply statistical methods to drive data-based decisions.

Qualifications

• Bachelor's degree in Engineering, Pharmaceutics, Industrial Pharmacy, or related field is required.
• 0–3 years of experience in Engineering, Pharmaceutics, Industrial Pharmacy or Pharmaceutical Manufacturing.
• Strong understanding of SOPs, validation, CAPA and regulatory readiness is preferred.

Responsibilities

• Support process/validation engineer to implement improvements and plant modifications.
• Monitor process performance and identify opportunities for yield, efficiency, quality, and equipment reliability improvements.
• Assist in process optimization and data analysis using statistical methods.
• Help prepare and update SOPs and assist with equipment installation and qualification protocols.
• Support technical services by troubleshooting and reviewing/developing validation documents and change controls.
• Generate reports and charts based on established statistical methods to drive improvements.
• Investigate deviations and perform root cause analysis to support CAPA implementation.
• Collaborate with cross-functional teams to ensure regulatory compliance (FDA, cGMP) and continuous improvement.

Skills

Process improvement

SOP development

Statistical analysis

CAPA

Root cause analysis

Education

Bachelor's degree in Engineering or related field

Master's degree in Engineering/Pharmaceutics (preferred)

Job description

Amneal Pharmaceuticals LLC is seeking an Associate Process Engineer to support the Operations and Engineering teams in implementing improvements, validation, and automation for manufacturing processes. The role includes SOP writing, process flow development, equipment validation, and collaboration across departments to ensure compliance and efficiency.

The candidate will assist in process optimization, monitor performance, and apply statistical methods to drive data-based decisions.