Senior Process Engineer
Amneal Pharmaceuticals
September 04, 2026
On-site
Piscataway, NJ
Operations
Essential Functions:
- Develop, author, and execute protocols to ensure compliance with FDA and cGMP requirements, including process validation, cleaning validation, and automated system/control qualification; monitor and analyze manufacturing data and support investigations for deviations/anomalies.
- Develop and manage technical plans, project scopes, design suitability studies, and implementation schedules; conduct feasibility assessments, risk analyses, budgeting, and execute projects; collaborate with R&D/Manufacturing to transition processes from development to scale-up and commercial production; evaluate/implement new technologies.
- Provide real-time troubleshooting for equipment/process deviations; lead training and develop manufacturing instructions; support start-up of new processes/equipment; monitor KPIs (quality, yield, throughput, cycle time, critical process parameters) to ensure cGMP, safety, and environmental compliance; partner with vendors to define system requirements and validate sterilization/decontamination/environmental control specifications.
- Serve as SME across sterile/aseptic, chemical/biological formulation, filling, packaging, and contamination-control operations; develop/revise SOPs; lead change controls and impact assessments; support root cause investigations and CAPA; contribute to process documentation and batch records.
Additional Responsibilities:
- Verify/develop P&ID, engineering layouts, drawings, and engineering documents.
- Apply project management to establish/track timelines, manage risks, and communicate across teams.
Qualifications:
- Education: BS/BA in Engineering/manufacturing/related (Required); MS/MA (Preferred).
- Experience: 5+ years in engineering roles in a GMP manufacturing environment/life science sterile/aseptic facility.
- Specialized Knowledge/Skills: strong cGMP/FDA knowledge; project management/leadership; problem-solving; communication/interpersonal skills; proficiency with relevant engineering software/tools.
Application instructions:
- Not provided in job description text.
- Develop, author, and execute protocols to ensure compliance with FDA and cGMP requirements, including process validation, cleaning validation, and automated system/control qualification; monitor and analyze manufacturing data and support investigations for deviations/anomalies.
- Develop and manage technical plans, project scopes, design suitability studies, and implementation schedules; conduct feasibility assessments, risk analyses, budgeting, and execute projects; collaborate with R&D/Manufacturing to transition processes from development to scale-up and commercial production; evaluate/implement new technologies.
- Provide real-time troubleshooting for equipment/process deviations; lead training and develop manufacturing instructions; support start-up of new processes/equipment; monitor KPIs (quality, yield, throughput, cycle time, critical process parameters) to ensure cGMP, safety, and environmental compliance; partner with vendors to define system requirements and validate sterilization/decontamination/environmental control specifications.
- Serve as SME across sterile/aseptic, chemical/biological formulation, filling, packaging, and contamination-control operations; develop/revise SOPs; lead change controls and impact assessments; support root cause investigations and CAPA; contribute to process documentation and batch records.
Additional Responsibilities:
- Verify/develop P&ID, engineering layouts, drawings, and engineering documents.
- Apply project management to establish/track timelines, manage risks, and communicate across teams.
Qualifications:
- Education: BS/BA in Engineering/manufacturing/related (Required); MS/MA (Preferred).
- Experience: 5+ years in engineering roles in a GMP manufacturing environment/life science sterile/aseptic facility.
- Specialized Knowledge/Skills: strong cGMP/FDA knowledge; project management/leadership; problem-solving; communication/interpersonal skills; proficiency with relevant engineering software/tools.
Application instructions:
- Not provided in job description text.