Associate Process Engineer - 12 Hour (Day Shift)
Amneal Pharmaceuticals
June 24, 2026
On-site
Piscataway, NJ
Operations
Associate Process Engineer provides support to Operation/Engineering leadership in implementing improvements, validation, and automation for plant operations. Supports development of SOPs, process flow, and review of design documents for new equipment procurement, including equipment validation.
Essential Functions:
- Support process/validation engineering by suggesting and implementing improvements; complete process simulations/optimization studies and implement modifications and process installations.
- Support day-to-day manufacturing by monitoring process performance and identifying improvement opportunities; optimize yield, efficiency, quality, and equipment reliability; analyze manufacturing data using statistical/analytical tools.
- Prepare/update SOPs; support equipment installation and operational qualifications; execute validation protocols, reports, and change controls; troubleshoot in the operations department; support protocol review and development.
- Generate statistical reports/charts/tables; investigate deviations/non-conformances; perform root cause analysis (RCA) and support CAPA implementation.
- Evaluate, improve, and validate current manufacturing practices/equipment for continuous improvement in productivity, quality, reliability, and consistency.
- Support equipment uptime; ensure compliance with FDA regulations and cGMP requirements and internal quality standards; collaborate cross-functionally for continuous improvement and regulatory readiness; communicate with vendors on material improvements.
Additional Responsibilities:
- Other duties as assigned.
- Write deviations and CAPA.
- Assist review of process-related documents.
Qualifications:
- Education: BS/BA in Engineering, Pharmaceutics, Industrial Pharmacy, or related field plus 3 years’ experience in Industrial Pharmacy or Engineering (in lieu of master’s). Master’s degree in Engineering preferred (Required).
- Preferred: MS/MA in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.
Experience:
- 3+ years in Engineering/Pharmaceutics/Industrial Pharmacy plus 3 years’ experience in Industrial Pharmacy or Engineering (in lieu of master’s).
Day shift: 12-hour rotating schedule (6:00am–6:30pm), 3 days week 1 and 4 days week 2; requires every other weekend.
Essential Functions:
- Support process/validation engineering by suggesting and implementing improvements; complete process simulations/optimization studies and implement modifications and process installations.
- Support day-to-day manufacturing by monitoring process performance and identifying improvement opportunities; optimize yield, efficiency, quality, and equipment reliability; analyze manufacturing data using statistical/analytical tools.
- Prepare/update SOPs; support equipment installation and operational qualifications; execute validation protocols, reports, and change controls; troubleshoot in the operations department; support protocol review and development.
- Generate statistical reports/charts/tables; investigate deviations/non-conformances; perform root cause analysis (RCA) and support CAPA implementation.
- Evaluate, improve, and validate current manufacturing practices/equipment for continuous improvement in productivity, quality, reliability, and consistency.
- Support equipment uptime; ensure compliance with FDA regulations and cGMP requirements and internal quality standards; collaborate cross-functionally for continuous improvement and regulatory readiness; communicate with vendors on material improvements.
Additional Responsibilities:
- Other duties as assigned.
- Write deviations and CAPA.
- Assist review of process-related documents.
Qualifications:
- Education: BS/BA in Engineering, Pharmaceutics, Industrial Pharmacy, or related field plus 3 years’ experience in Industrial Pharmacy or Engineering (in lieu of master’s). Master’s degree in Engineering preferred (Required).
- Preferred: MS/MA in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.
Experience:
- 3+ years in Engineering/Pharmaceutics/Industrial Pharmacy plus 3 years’ experience in Industrial Pharmacy or Engineering (in lieu of master’s).
Day shift: 12-hour rotating schedule (6:00am–6:30pm), 3 days week 1 and 4 days week 2; requires every other weekend.