Associate Process Engineer
Amneal Pharmaceuticals
16 days ago
On-site
Piscataway, NJ
Operations
The Process Engineer provides support to Plant Operations/Engineering to implement improvements, validation, and automation.
Responsibilities:
- Support process/validation engineering by suggesting and implementing improvements; complete process simulations/optimization studies; implement modifications and process installations.
- Support day-to-day manufacturing operations by monitoring process performance; identify improvement opportunities; optimize yield, efficiency, quality, and equipment reliability; analyze manufacturing data with 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/development.
- Generate reports/charts/tables; investigate deviations/non-conformances; perform root cause analysis (RCA); support CAPA implementation.
- Evaluate/improve/validate manufacturing practices and equipment for continuous improvement (productivity, quality, reliability, consistency).
- Support equipment uptime; ensure compliance with FDA regulations, cGMP, and internal quality standards; collaborate cross-functionally; communicate with vendors about material improvements.
Additional responsibilities:
- Write deviation and CAPA; assist review of process-related documents; other duties as assigned.
- Day shift: 12-hour per day, rotating schedule (6:00am–6:30pm), 3 days week 1 and 4 days week 2 of pay cycle.
Qualifications:
- Required: Bachelor’s (BA/BS) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field plus 3 years’ experience in Industrial Pharmacy or Engineering (in lieu of master’s).
- Preferred: Master’s (MS/MA) in a related field.
Experience:
- 3+ years in Engineering/Pharmaceutics/Industrial Pharmacy, plus 3 years’ related experience (or equivalent per above). Salary range: $65,000–$75,000/year; 401(k) matching and health/insurance benefits mentioned.
Responsibilities:
- Support process/validation engineering by suggesting and implementing improvements; complete process simulations/optimization studies; implement modifications and process installations.
- Support day-to-day manufacturing operations by monitoring process performance; identify improvement opportunities; optimize yield, efficiency, quality, and equipment reliability; analyze manufacturing data with 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/development.
- Generate reports/charts/tables; investigate deviations/non-conformances; perform root cause analysis (RCA); support CAPA implementation.
- Evaluate/improve/validate manufacturing practices and equipment for continuous improvement (productivity, quality, reliability, consistency).
- Support equipment uptime; ensure compliance with FDA regulations, cGMP, and internal quality standards; collaborate cross-functionally; communicate with vendors about material improvements.
Additional responsibilities:
- Write deviation and CAPA; assist review of process-related documents; other duties as assigned.
- Day shift: 12-hour per day, rotating schedule (6:00am–6:30pm), 3 days week 1 and 4 days week 2 of pay cycle.
Qualifications:
- Required: Bachelor’s (BA/BS) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field plus 3 years’ experience in Industrial Pharmacy or Engineering (in lieu of master’s).
- Preferred: Master’s (MS/MA) in a related field.
Experience:
- 3+ years in Engineering/Pharmaceutics/Industrial Pharmacy, plus 3 years’ related experience (or equivalent per above). Salary range: $65,000–$75,000/year; 401(k) matching and health/insurance benefits mentioned.