Senior Process Engineer
Amneal Pharmaceuticals
9 hours ago
On-site
Brookhaven, NY
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 to identify improvements and support investigations for deviations/anomalies.
- Develop and manage technical plans, project scopes, design suitability studies, and implementation schedules to establish manufacturing process capability and support new/reformulated products. Conduct feasibility assessments, risk analyses, budgeting, and execute projects with business objectives; collaborate with R&D and Manufacturing to transition from development to scale-up and commercial production. Evaluate and implement new technologies.
- Provide real-time troubleshooting for equipment failures and process deviations. Lead personnel training; develop manufacturing instructions; support startup of new processes/equipment. Monitor KPIs (quality, yield, throughput, cycle time, critical process parameters) to drive improvements and ensure compliance with cGMP, safety, and environmental requirements. Collaborate with vendors to define requirements and validate functional specifications.
- Serve as SME for sterile/aseptic manufacturing: chemical/biological formulation, filling, packaging, contamination-control operations. Develop/revise SOPs; lead change controls and impact assessments. Support/lead investigations for root cause analysis and CAPA. Contribute to process documentation and batch records.
Additional Responsibilities:
- Verify/develop P&ID, engineering layouts, and engineering drawings/documents.
- Apply project management principles: timelines, risk mitigation, cross-team communication.
Qualifications:
- Education: BS/BA in Engineering, manufacturing, or related field (Required); MS/MA (Preferred).
- Experience: 5+ years in engineering roles in a GMP sterile/aseptic facility.
- Specialized Knowledge/Skills: Strong cGMP/FDA/regulatory knowledge; project management/leadership; problem-solving and decision-making; communication/interpersonal skills; proficiency with relevant engineering software/tools.
- Additional Requirement: Successful completion of an OSHA-compliant Respirator Fit Test.
Benefits/Compensation:
- Base salary range: $110,000–$115,000 per year.
- 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 to identify improvements and support investigations for deviations/anomalies.
- Develop and manage technical plans, project scopes, design suitability studies, and implementation schedules to establish manufacturing process capability and support new/reformulated products. Conduct feasibility assessments, risk analyses, budgeting, and execute projects with business objectives; collaborate with R&D and Manufacturing to transition from development to scale-up and commercial production. Evaluate and implement new technologies.
- Provide real-time troubleshooting for equipment failures and process deviations. Lead personnel training; develop manufacturing instructions; support startup of new processes/equipment. Monitor KPIs (quality, yield, throughput, cycle time, critical process parameters) to drive improvements and ensure compliance with cGMP, safety, and environmental requirements. Collaborate with vendors to define requirements and validate functional specifications.
- Serve as SME for sterile/aseptic manufacturing: chemical/biological formulation, filling, packaging, contamination-control operations. Develop/revise SOPs; lead change controls and impact assessments. Support/lead investigations for root cause analysis and CAPA. Contribute to process documentation and batch records.
Additional Responsibilities:
- Verify/develop P&ID, engineering layouts, and engineering drawings/documents.
- Apply project management principles: timelines, risk mitigation, cross-team communication.
Qualifications:
- Education: BS/BA in Engineering, manufacturing, or related field (Required); MS/MA (Preferred).
- Experience: 5+ years in engineering roles in a GMP sterile/aseptic facility.
- Specialized Knowledge/Skills: Strong cGMP/FDA/regulatory knowledge; project management/leadership; problem-solving and decision-making; communication/interpersonal skills; proficiency with relevant engineering software/tools.
- Additional Requirement: Successful completion of an OSHA-compliant Respirator Fit Test.
Benefits/Compensation:
- Base salary range: $110,000–$115,000 per year.